South Africa

Authority: South African Health Products Regulatory Authority (SAHPRA)
Legal basis: Not recorded
Address: Not recorded
Website: https://www.sahpra.org.za
Notice channel: https://www.sahpra.org.za/product-recalls/
HTML index linking PDF recall letters, plus a separate safety-information channel for DHCPLs.
Coverage: Captured
Cadence: Daily
On the register: 121 recorded actions
Last verified: 6 September 2026

Authority Channel

A named officer of SAHPRA can put a South Africa alert on the register directly, with no review step of ours. Those records carry Tier 0 — entered and published by the issuing regulator, which is the one rank we cannot create for ourselves.

Nothing on this page carries Tier 0 today because no SAHPRA officer holds a credential yet. We issue one after confirming, out of band, that a person speaks for their authority — write to notices@drugeyeafrica.org. Notices can also be sent by email, by export, or from an existing system: how to send them.

Data

Filter the register to South Africa

What we monitor, and what we cannot. The recall letters are not on SAHPRA's own servers: of 98 rows read on 2026-09-06, 66 link a letter on Google Drive and 26 on SharePoint. Records cite SAHPRA's own document page instead, and the letters are archived on ingest. The index states no manufacturer and no batch and heads its date column Date Updated rather than the date of the recall; each document page states all three, and those are what the register now holds. 91 of 99 records carry lot numbers and none is undated. Cadence: Daily. Last checked 6 September 2026.

Actions issued by SAHPRA

121 shown

Reference	Date	Country	Product	Batches	Action	Class	Source
DEA-ZA-2026-19360067	28 Aug 2026	ZA	BiCOAG Hemostasis Probe	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-80467224	27 Aug 2026	ZA	Bravo™ CF capsule delivery device, 5-pk & 1-pk	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-33340766	25 Aug 2026	ZA	Imager™ II Angiographic Catheter	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-15542090	25 Aug 2026	ZA	Ciplasyl Plus 4 tablets Zydus Healthcare SA (Pty) Ltd	MA04847A · MB02129A · MA04848A · MA04900A · MB02127A · MB02128A	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-99085454	24 Aug 2026	ZA	CARDIOROOT Woven grafts	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-59491904	21 Aug 2026	ZA	INFrame™ Implant 2.0mm x 28mm and INFrame™ Implant 2.0mm x 34mm	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-92753242	12 Aug 2026	ZA	Percutaneous Insertion Kits 100 and 150 (PIK)	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-36046338	12 Aug 2026	ZA	ZS70658 – VAC TUBE CLOT ACTIV+GEL SEP 5mL (2 4mL)	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-37877187	07 Aug 2026	ZA	Smart Bag Flexpack Acid Concentrates	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-27054725	31 Jul 2026	ZA	Frusemide 20 mg/2 ml Fresenius (Furosemide) Fresenius Kabi South Africa (Pty) Ltd	90TEA870 · 90TIA300 · 90TKB190 · 90TLA480 · 90UCA000 · 90UEA840 · 90UIA510 · 90UIA530 · 90WEA230	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-31671464	29 Jul 2026	ZA	Enalapril 10mg Arya Arya Pharma Pty Ltd	GQQ24066 · GQQ24064 · GQQ24067 · GQQ24053	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-47164635	21 Jul 2026	ZA	Nintedanib 100 mg Cipla and Nintedanib 150 mg Cipla	6KA0781 · 6KA0782	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-29539746	20 Jul 2026	ZA	Homechoice Automated PD set with cassette and 4-Prong luers	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-85341124	17 Jul 2026	ZA	Evo Aqueous Cream BP 500g Evohealth (Pty) Ltd	030 · 44	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-46579469	17 Jul 2026	ZA	ENO Active Fruit Salt Regular Haleon South Africa (Pty) Ltd	V79A	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-82045477	08 Jul 2026	ZA	Dynadol IV (Paracetamol)	GN 6387 · GN 6388 · GN 7230 · GN 7232	Recall	Class I	Tier 1 · Regulator-published
DEA-ZA-2026-99800547	30 Jun 2026	ZA	Lerumo Immunity Bio Services CC	260401 · 251003 · 260104 · 260302 · 260216	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-63300703	03 Jun 2026	ZA	Afterwash (Diphoterine Solution)	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-95579305	27 May 2026	ZA	CRE™ Wireguided Balloon Dilatation Catheter	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-22761407	22 May 2026	ZA	iDEXIS Semaglutide, iDEXIS Tirzepatide, iDEXISSemaglutide/Tirzepatide	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-28997660	21 May 2026	ZA	Optase Dry Eye Intense Drop (Glycerol 0.2%)	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-87003131	20 May 2026	ZA	Ranceph Suspension 125 Mg/5 ML (Cephalexin Monohydrate) Ranbaxy Pharmaceuticals (Pty) Ltd	DFG4606A	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-80622375	19 May 2026	ZA	Bobby Balloon Guide Catheter	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-69116262	19 May 2026	ZA	Residual Barrier Technology (RBT) Protectus Med 1lt	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-57462202	18 May 2026	ZA	Mx-ava 500 Mpat Syringe Set Multi Patient	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-95041490	14 May 2026	ZA	TCNTM (Thermo Couple Nitinol) and CSKTM (Cosman Straight Kit) Reusable Radiofrequency (RF) Electrodes	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-81097468	14 May 2026	ZA	Mixing Bowl and Spatula, 20-pack	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-37831102	14 May 2026	ZA	Pepta AC Gel (Magnesium Carbonate light, Magnesium Trisilicate, Sodium bicarbonate) Asante Pharma	B250515 · B260383 · B260382 · B250514	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-53911652	08 May 2026	ZA	Aspelone (Prednisolone Sodium Phosphate) Pharmacare Limited trading as Aspen Pharmacare	E0023605	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-27550567	06 May 2026	ZA	POLARx and POLARx FIT Cryoablation Catheters, POLARSHEATH Steerable Sheaths, and SMARTFREEZE Consoles	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-77397567	04 May 2026	ZA	Apixaban 2,5 DRL (Apixaban) Dr Reddy's Laboratories (Pty) Ltd	T2504569	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-51468298	04 May 2026	ZA	Halaven (Eribulin)	148482	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-22659282	04 May 2026	ZA	OXOID™ Agglutinating Sera, Salmonella 9-0	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-83149863	24 Apr 2026	ZA	Ciprofloxacin 250 MG Austell (Ciprofloxacin Hydrochloride) Austell Pharmaceuticals (Pty) Ltd	AEW014001	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-38832956	20 Apr 2026	ZA	Cipla-Pioglitazone Hydrochloride 15 (Pioglitazone Hydrochloride) Cipla Medpro (Pty) Ltd	4GC0350 · GC30719	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-31245121	20 Apr 2026	ZA	Visipaque (Iodixanol)	17244629	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-0061	20 Apr 2026	ZA	Contrast media (iohexol)	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-31800274	17 Apr 2026	ZA	Kiwi Complete Vacuum Delivery System	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-62631082	17 Mar 2026	ZA	Citro-Soda (Sodium bicarbonate, Tartaric acid, Citric acid, Sodium citrate) Adcock Ingram Limited	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-24377231	10 Mar 2026	ZA	Supiroban Ointment (Mupirocin 20mg/g) Glenmark Pharmaceuticals South Africa (Pty) Ltd	19242129	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-59104926	06 Mar 2026	ZA	Gastrografin (Meglumine amidotrizoate + Sodium amidotrizoate solution 0.76 g/mL)	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-32082410	06 Mar 2026	ZA	Urografin (Meglumine amidotrizoate + Sodium amidotrizoate solution 0.76 g/mL) Cipla Medpro (Pty) Ltd	MA04VPS · MA04V7D · MA04SJ4 · MA04R29 · MA04SRF · MA04X07	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2026-48225894	30 Jan 2026	ZA	Sereflo 25/125 HFA Cipla Medpro (Pty) Ltd	5IB0093	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-98097656	19 Dec 2025	ZA	Sodium Fluoride 0.55mg/4 drops equivalent to 0,25 mg fluoride. (Zymafluor Oral Drops) Viatris South Africa (Pty) Ltd	2304254	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-15507390	18 Dec 2025	ZA	Flucloxacillin 250 Capsules (Flucloxacillin 250 Oethmaan)	MP25071 · MP25072 · MP25073 · MP25151 · MP25152 · MP25224 · MP25225 · MP25257	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-86797663	02 Dec 2025	ZA	Ondansetron HCL 8mg tablet (Zothena 8 mg) Eurolab (Pty) Ltd	2430701	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-0000-78644818	02 Dec 2025	ZA	Ondansetron HCL 4mg tablet (Zothena 4 mg)	2430601	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2025-12468498	28 Nov 2025	ZA	Metronidazole 400mg tablet (Bemetrazole 400mg) Ranbaxy Pharmaceuticals (Pty) Ltd	BTF1332A	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-61562216	26 Nov 2025	ZA	CISATRACURIUM BESYLATE 2mg/ml Ampoule for Injection (Nimbex (2mg/ml)) Aspen SA Sterile Operations (Pty) Ltd	XP1YM · 301950 · 301940 · XPC4M	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-32912100	26 Nov 2025	ZA	MIVACURIUM CHLORIDE 10mg/5ml Ampoule for Injection (Mivacron (10mg/5ml)) Aspen SA Sterile Operations (Pty) Ltd	XPC2S · 302080	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-19108373	26 Nov 2025	ZA	ATRACURIUM BESILATE 10mg/ml Ampoule for Injection (Tracrium (10mg/ml)) Aspen SA Sterile Operations (Pty) Ltd	XP1W5 · 301910	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-28218111	19 Sept 2025	ZA	Afrox Compressed Medical Air African Oxygen Ltd	ZACFAATBDB · ZACFAAV3HK · ZACFAAVYZW · ZACFAAV7W9 · ZACFAAWGR6 · ZACFAAWJJB · ZACFAAXASM · ZACFAAW3QW · ZACFAAXBY6 · ZACFAAXHVJ · ZACFAAXJH6 · ZACFAAXKUC · ZACFAAXSQP · ZACFAAXP76 · ZACFAAX2Z7 · ZACFAAX2H8 · ZACFAAYASD · ZACFAAY2G2 · ZACFAAY6BU · ZACFAAZCMA · ZACFAAY8VF · ZACFAAZL76 · ZACFAAZEYC · ZACFAAZGMS · ZACFAAZRHV · ZACFAAZR4Q · ZACFAAZW53 · ZACFAAZ9GZ · ZACFAAZ3LJ · ZACFAAZ4LE · ZACFAA2MEC · ZACFAA2UYE · ZACFAA2Y7F · ZACFAA27C9 · ZACFAA3BH6 · ZACFAA3KUF · ZACFAA3Q4E · ZACFAA3LZ2 · ZACFAA3SHB · ZACFAA3VE6 · ZACFAA355Q · ZACFAA4DME · ZACFAA37R6 · ZACFAA4BNL · ZACFAA39GF · ZACFAA4JSF · ZACFAA4GYB · ZACFAA4L8E · ZACFAA4NKF · ZACFAA4FXH · ZACFAA4RZ7 · ZACFAA4V7B · ZACFAA4TJW · ZACFAA426S · ZACFAA49NU · ZACFAA46DR · ZACFAA5HHV · ZACFAA54DR · ZACFAA526G · ZACFAA6EHZ · ZACFAA6A4B · ZACFAA6CL3 · ZACFAA6BEL · ZACFAA6FQF · ZACFAA6JKF · ZACFAA6LFF · ZACFAA6ML2 · ZACFAA6SKG · ZACFAA6SFQ · ZACFAA6SVT · ZACFAA62EP · ZACFAA62GK · ZACFAA6Y8C · ZACFAA67MN · ZACFAA69ME · ZACFAA7FDX · ZACFAA7HBT · ZACFAA7PFU · ZACFAA7NE2 · ZACFAA7V6N · ZACFAA77UX · ZACFAA8AG3 · ZACFAA8HXC · ZACFAA8DT4 · ZACFAA8CT8 · ZACFAA8LWZ · ZACFAA8P4A · ZACFAA8THX · ZACFAA8V95 · ZACFAA8W2G · ZACFAA8ZQQ · ZACFAA9FAM · ZACFAA92R9 · ZACFAA9WYC · ZACFAA99W4 · ZACFAA94TV · ZACFABABD8 · ZACFABADA6 · ZACFABAR7R · ZACFABAZMV · ZACFABBKBZ · ZACFABBEVK · ZACFABBMAT · ZACFABB4R4 · ZACFABCDLZ · ZACFABCAVT · ZACFABCG3N · ZACFABCM7R · ZACFABCKTS · ZACFABCUSP · ZACFABDDAE · ZACFABC9T3 · ZACFABDSH9 · ZACFABDT8Q · ZACFABEDFR · ZACFABD8A2 · ZACFABESSF · ZACFABFBXN · ZACFABFD43 · ZACFABFAPA	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-26975862	19 Sept 2025	ZA	Pearinda 4 mg (Perindopril) Pharma Dynamics (Pty) Ltd	002120	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-52003215	15 Sept 2025	ZA	Pectin K suspension (Kaolin 3 g Pectin 0,220 g) Pharmacorp (Pty) Ltd	133 · 134	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-26695701	14 Aug 2025	ZA	Fucidin 250 Mg Film-coated Tablets (Section 21 product)	C97098	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-12801665	04 Jul 2025	ZA	Ludiomil 25 mg Film-Coated Tablets (Maprotiline hydrochloride)	F0016	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-29587762	30 Jun 2025	ZA	Hetovanil 62,5 / 25 mg & 250 / 100 mg Hetero Drugs South Africa (Pty) Ltd	FD243828A · ATP24014C	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-66212182	27 Jun 2025	ZA	Somatuline Autogel 90mg & 120mg (Lanreotide acetate) Acino Pharma (Pty) Ltd	003361 · 005988 · 009540 · 002243 · 002956 · 006373	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-20878416	25 Jun 2025	ZA	ACCORD-VINCRISTINE 1 mg/ml, 2ml (Vincristine Sulfate)	M2309730	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-81897951	19 May 2025	ZA	Dis-Chem Paracetamol (Paracetamol) Phyto OTC Health (Pty) Ltd	1557	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-72529949	16 May 2025	ZA	Aflibercept 40mg/ml Intravitreal Injection (Aflibercept 40mg/ml) Eurolab ASU, a division of Eurolab (Pty) Ltd	AFL031023 · AFL0310723 · AFL0310822 · AFLO310921 · AFL0311023	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-67711659	16 May 2025	ZA	Bevacizumab 25mg/ml Injection (Bevacizumab 25mg/ml) Eurolab ASU, a division of Eurolab (Pty) Ltd	BEV0300622	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-68322700	31 Mar 2025	ZA	Smecta Go (Diosmectite) Acino Pharma (Pty) Ltd	W12706 · W18869 · W19120 · W19246 · C51926 · C57569	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-87765147	10 Mar 2025	ZA	Fertomid-50 Tablets (Clomiphene Citrate 50 mg) Cipla Medpro (Pty) Ltd	GH21051	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2025-68374388	10 Mar 2025	ZA	Haemosolvate® Factor VIII 500 IU5ml National Bioproducts Institute NPC	V8T1613	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2024-92988845	09 Dec 2024	ZA	Panado Paediatric Alcohol Free-Grape Flavour (Paracetamol 120,0 mg / 5 ml) Adcock Ingram Limited	C122061 · C122063 · C122620 · C127913 · C122062 · C126891	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2024-22819627	09 Dec 2024	ZA	Adco Midazolam Injection 5mg/5ml (Midazolam) Adcock Ingram Critical Care Pty Ltd	S3330	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2024-90642188	21 Nov 2024	ZA	ETORICOXIB 60 AUSTELL (ETORICOXIB 60,0 mg) Austell Pharmaceuticals	AGT4001	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2024-61515988	21 Nov 2024	ZA	YAZ PLUS (DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,02 mg LEVOMEFOLATE CALCIUM 0,451 mg)	WEW96J	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2024-22798746	21 Nov 2024	ZA	Amipro Advanced Development Products (Pty) Ltd Products	none published	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2024-59064800	14 Oct 2024	ZA	Monofer 500mg/5ml (Iron (III) isomaltoside)	230504A-5	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2024-17736979	03 Sept 2024	ZA	Zinium Infant Drops	5890 · 5943 · 6981	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2024-81128832	29 Aug 2024	ZA	Dovate Cream (Clobetasol Propionate) Pharmacare Ltd t/a Aspen Pharmacare	E0012547	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2024-88802970	18 Aug 2024	ZA	Bemetrazole 400mg Tablets (Metronidazole) Ranbaxy Pharmaceuticals (Pty) Ltd	AC80212 · AC80213	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-2024-53403875	22 Jul 2024	ZA	Coralan 7.5 mg Tablets (Ivabradine 7.5mg) Servier (Pty) Ltd	719715 · 709702 · 705182 · 701085 · 705921 · 715957 · 697702	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-0000-66130150	08 Jul 2024	ZA	NEXIPRAZ IV (Esomeprazole 40mg) Ranbaxy Pharmaceuticals (Pty) Ltd	HAE3136A	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-0000-23102253	04 Jul 2024	ZA	ZINERYT LOTION (Erythromycin 40 mg/ml and Zinc acetate 12 mg/ml) Adcock Ingram Limited	66869	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2024-95517888	14 Jun 2024	ZA	Ketamine 50 mg/1 ml Fresenius (Ketamine Hydrochloride) Fresenius Kabi Manufacturing South Africa (Pty) Ltd	90SKB230	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-0000-54250818	01 Jun 2024	ZA	Emistop 4 mg (Ondansetron 4 mg) Pharma Dynamics (Pty) Ltd	B5G0138A	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2024-76102271	24 Apr 2024	ZA	Zinium Junior Diabetic Friendly Syrup and Zinium Junior Syrup iNova Pharmaceuticals (Pty) Ltd	5661 · 5521 · 5958 · 5322 · 6766 · 6977 · 5955 · 6079 · 5834	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2024-32671519	11 Apr 2024	ZA	Benylin Paediatric Syrup (each 5 ml contains 7 mg Diphenhydramine HCl) Kenvue	329303 · 329304	Recall	Class I	Tier 1 · Regulator-published
DEA-ZA-0000-78490726	05 Feb 2024	ZA	Arthrexin 25 capsules (indomethacin 25mg) Pharmacare Limited t/a Aspen Pharmacare	P0003739	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2024-68751182	10 Jan 2024	ZA	Acenten 20/12,5 mg Tablets (Enalapril Maleate 20 mg and Hydrochlorothiazide 12.5mg) Austell Pharmaceuticals	JTU022001 · JTU022002	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-0000-49890057	08 Jan 2024	ZA	Novomix Injection 30 Penfil, 3 ml (100 units of Insulin Aspart) Novo Nordisk (Pty) Ltd	NR7SE13	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2023-21556129	18 Dec 2023	ZA	Lubri-A sterile lubricating sachets (Glycerine (B.P. or U.S.P) 9.9% m/m) EletroSpyres HealthCare	M204 · M205 · M085 · M108 · M156 · M109	Recall	Class I	Tier 1 · Regulator-published
DEA-ZA-0000-64815136	05 Dec 2023	ZA	Histagex syrup (Chlorphenamine maleate 2mg/5 ml) RESMED HEALTHCARE	none published	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-0000-62694248	05 Dec 2023	ZA	Resmed Elemental Zinc Syrup (Elemental Zinc 10mg/5 ml)	none published	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2023-47700295	04 Dec 2023	ZA	Semaglutide (API)	23022832	Recall	Class I	Tier 1 · Regulator-published
DEA-ZA-2023-95870759	28 Nov 2023	ZA	Berocca Performance Mango Tablets Bayer (Proprietary) Ltd	43782 · 43783 · 43384	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-0000-16030580	02 Nov 2023	ZA	Deplatt Tablets (Clopidogrel 75 mg) Trinity Pharma (Pty) Ltd	BT40J001	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2023-31893631	02 Aug 2023	ZA	0.9% Sodium Chloride Infusion B. Braun solution for infusion (9mg/ ml sodium chloride) B.Braun Medical (Pty) Ltd	21154408 · 21155407	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2023-17724042	07 Jul 2023	ZA	Dopaquel 300mg film-coated tablets (Quetiapine fumarate) Dr Reddy’s Laboratories (Pty) Ltd	C2300635	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2023-69589526	24 May 2023	ZA	Amuco 600 Effervescent Tablet (Acetylcysteine 600mg) Austell Pharmaceuticals	42332 · 42333 · 42334 · 42386 · 42387 · 42388 · 42389	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2023-61422478	23 Mar 2023	ZA	PHOLTEX SYRUP Range: Pholtex Junior; Pholtex Forte and Pholtex Plus iNova Pharmaceuticals (Pty) Ltd	none published	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-0000-50104820	01 Feb 2023	ZA	CELESTONE SOLUSPAN Suspension for injection (Betamethasone acetate/ Betamethasone sodium phosphate suspension) Organon South Africa (Pty) Ltd	W002691 · U040010 · W007137	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2023-17459996	30 Jan 2023	ZA	Zodoray 0.25 μg capsules (Alfacalcidol). Strides Pharma SA (Pty) Ltd	7250117	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2022-75511846	12 Dec 2022	ZA	FLOMIST NASAL SPRAY (Fluticasone Propionate 50 mcg/ spray) Cipla Medpro (Pty) Ltd	IC20685	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2022-89999428	21 Oct 2022	ZA	CP Sports Infusion” (Glutathione: 2g/50ml) Compounding Pharmacy of South Africa (CPSA)	IV44762 · IV44821 · IV44830 · IV44856	Recall	Class I	Tier 1 · Regulator-published
DEA-ZA-2022-88598902	17 Oct 2022	ZA	Lasix 80 mg tablets (furosemide 80 mg)	CG022A	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2022-80856992	17 Oct 2022	ZA	Lumont 10 mg tablets (montelukast)	108011	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2022-44502141	10 Oct 2022	ZA	Mizart 80 mg tablets (telmisartan 80 mg)	8130141	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2022-71101782	07 Oct 2022	ZA	Andolex-C Oral Gel (benzydamine HCL 10 mg/cetylpyridinium Cl 1 mg/g)	126355 · 127226	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2022-51900791	29 Sept 2022	ZA	Austell Azithromycin (Azithromycin 200 mg/5 ml powder for suspension) Austell Pharmaceuticals	MG22413 · MG22414 · MG22415	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-0000-99566099	12 Sept 2022	ZA	Lancap 15mg capsules (Lansoprazole) Pharma Dynamics (Pty) Ltd	SJ2758 · SJ3425 · SJ2652 · SJ8693	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2022-15858179	09 Sept 2022	ZA	Vitaforce Schlehen Blackthorn Berry Elixir (Ascorbic acid (Vit C) 33,5 mg) Ascendis Consumer Brands (Pty) Ltd	151717 · 151848 · 151725 · 151844 · 152003	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2022-46630416	05 Sept 2022	ZA	JANUMET 50/850mg and JANUMET 50/1000mg (50mg of Sitagliptin with 850mg of Metformin Hydrochloride AND 50mg of Sitagliptin with 1000mg of Metformin Hydrochloride)	W01552 · W01553	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-0000-14147041	04 Jul 2022	ZA	Demetrin 10mg (prazepam) Pfizer Laboratories (Pty) Ltd	DT3236	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2022-60994194	01 Jul 2022	ZA	Rocephin 1G injection (1 vial with dry substance equivalent to 1g ceftriaxone + 1 ampoule water for injection 10ml) Roche products (Pty) Ltd	B0757B04	Recall	Class I	Tier 1 · Regulator-published
DEA-ZA-2022-39751206	23 Jun 2022	ZA	Adco-Napacod tablets (Paracetamol 500 mg and Codeine Phosphate 10mg) Adcock Ingram Limited	AD0433 · AC1264	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2022-58893384	15 Jun 2022	ZA	Coryx Throat Spray (Benzocaine and chlorhexidine gluconate solution 20 %) Cipla Medpro (Pty) Ltd	ZB000156 · ZB000157 · ZB000158 · ZB000159 · ZB000160 · ZB100105 · ZB100107 · ZB100172	Recall	Class I	Tier 1 · Regulator-published
DEA-ZA-2022-11171194	26 May 2022	ZA	PROTA 50 mg/ 5 ml (Protamine Sulphate – Ampoules for IV injection)	IPTAA1203	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2022-29940179	18 May 2022	ZA	Lactulose concentrate API (Lactulose Concentrate solution- 66% and 70% )nsoprazole) Lacsa (Pty) Limited	P3915 · P3822 · P3823 · P3841 · P3912 · P3913 · P3916 · P3919	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2022-53176611	25 Apr 2022	ZA	Accumax 10mg and 20 mg Film Coated Tablet (QUINAPRIL HYDROCHLORIDE) Pfizer Laboratories (Pty) Ltd	CK8048 · DC6880 · DM5063	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-2022-40914018	22 Apr 2022	ZA	OsvaRen 435mg_235 film coated tablets Fresenius Medical Care South Africa (PTY) Ltd.	ZC015 · 200 · ZOAK08100 · ZOAK04 · ZC016100 · ZOAK04300 · ZOAK05200 · ZOAK08300	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2022-50423430	28 Jan 2022	ZA	Oranix Solution (oral rinse) (Benzydamine HCl 22,5 mg/15 ml; Chlorhexidine gluconate 18,0 mg/15 ml) iNova Pharmaceuticals (Pty) Ltd	126189	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2022-46331090	24 Jan 2022	ZA	DERMADINE ORAL ANTISEPTIC solution (Povidone-iodine 1,00 g (1 % m/v))	120983	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2022-48165170	11 Jan 2022	ZA	Azacitidine DRL 100mg Lyophilized powder for Injection (Azacitidine) Dr. Reddy's Laboratories Limited	H210418	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2021-95393706	13 Jul 2021	ZA	Panado 500mg Tablets (paracetamol) Adcock Ingram limited	AC1696	Recall	Class II	Tier 1 · Regulator-published
DEA-ZA-0000-99315991	undated	ZA	Steris VERFIY Dual Specific Self-Contained Biological Indicators for Steam and ETO (S3060)	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-0000-69400921	undated	ZA	NDI Passive Sphere™ – Model No. 8801071, 8801074, 8801075 & Medtronic Biopsy Needle Kit – Model No. 9733068	none published	Recall	Unclassified	Tier 1 · Regulator-published
DEA-ZA-0000-48068664	undated	ZA	Single Use Distal Cover – Model: MAJ-2315	none published	Recall	Unclassified	Tier 1 · Regulator-published

Acted on elsewhere, relevant here

Cross-border

Reference	Date	Country	Product	Batches	Action	Class	Source
DEA-XXX-2026-0001	07 May 2026	XX	ACCUPAQUE (Iohexol), OMNIPAQUE (Iohexol) and VISIPAQUE (Iodixanol)	none published	Public warning	Unclassified	Tier 1 · Regulator-published
DEA-KE-2026-0009	07 May 2026	KE	Omnipaque 350mg GE HealthCare, Ireland	17212392	Recall	Unclassified	Tier 1 · Regulator-published
DEA-EG-2026-0025	Apr 2026	EG	Omnipaque 300 mg/ml GE healthcare Ireland	17350896 · 17334249	Recall	Class II	Tier 1 · Regulator-published
DEA-BW-2024-93841841	16 Apr 2024	BW	Benylin Paediatric 100mls Cough Syrup Johnson & Johnson (Pty) Ltd	329304 · 329303	Recall	Unclassified	Tier 1 · Regulator-published
DEA-RW-2024-0088	12 Apr 2024	RW	Benylin	329304	Recall	Class I	Tier 1 · Regulator-published

Actions by other authorities that name this market on the notice, or that belong to a cross-border event this market also appears in. An absence here is an absence of recorded links, not a statement that no such product is on this market.