Monthly reportSAHPRA

South African Health Products Regulatory Authority — November 2025

What this register recorded from SAHPRA in November 2025, what other African authorities published in the same month that bears on it, and what we could not read in SAHPRA’s own notices. Every figure here is a count of published regulatory actions. None of it is a finding about South African Health Products Regulatory Authority.

What SAHPRA published

4 action(s) recorded: 4 recall.

Reference	Date	Country	Product	Batches	Action	Class	Source
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-2025-32912100	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-2025-61562216	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-2025-12468498	28 Nov 2025	ZA	Metronidazole 400mg tablet (Bemetrazole 400mg) Ranbaxy Pharmaceuticals (Pty) Ltd	BTF1332A	Recall	Unclassified	Tier 1 · Regulator-published

What other authorities published

Nothing published elsewhere this month joins to SAHPRA by either of the two links this register will draw — a shared event, or a manufacturer SAHPRA has itself named. That is a statement about those two links and not about the month.

What we could not read in SAHPRA’s notices

Our failures on SAHPRA’s coverage, across the whole register rather than this month. Published because a report that told an authority only what it was missing would be an audit sent by someone with no standing to conduct one.

121 record(s) held from SAHPRA in total
0 carry no publication date we could read
25 name neither a batch nor a stated reason
48 name no manufacturer
25 are searchable and API-available but carry noindex, because they are too incomplete for a public URL
23 have no archived copy of the original notice

Each of these is something SAHPRA published and this register did not capture, or captured incompletely. None of them is a failure by SAHPRA.

Correcting this

Anything on this page that is wrong about South African Health Products Regulatory Authority can be corrected by South African Health Products Regulatory Authority, and a record published by one of its officers carries verification tier 0 — the rank only the issuing regulator can create. Nothing else on this register does.

Write to notices@drugeyeafrica.org. Corrections to existing records are logged and published on the corrections page; a superseded record keeps its URL and points forward to the one that replaced it.

Every month for SAHPRA · South Africa · The authorities we read · How this register’s coverage is assessed