Botswana

Authority: Botswana Medicines Regulatory Authority (BOMRA)
Legal basis: Not recorded
Address: Not recorded
Website: https://www.bomra.co.bw
Notice channel: https://www.bomra.co.bw/safety-alerts/
Safety alerts plus regulatory notices and consultations.
Coverage: Captured
Cadence: Weekly
On the register: 1 recorded action
Last verified: 5 September 2026

Authority Channel

A named officer of BOMRA can put a Botswana 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 BOMRA 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 Botswana

What we monitor, and what we cannot. One to three safety alerts a year, mostly echoes of international actions. Most of what BoMRA publishes is not an action against a product: 13 of its 14 records are safety communications about an active substance or a drug class, or guidance on the rules themselves, and the one that is an action is a recall BoMRA was reporting on NAFDAC's behalf, and those are published on the country page rather than the register because no batch search can answer a question about a whole class. The channel states no batch numbers and no manufacturer; both are inside the letters. Cadence: Weekly. Last checked 5 September 2026.

Actions issued by BOMRA

1 shown

Reference	Date	Country	Product	Batches	Action	Class	Source
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

Safety communications and guidance

13 shown

Reference	Date	Country	Notice	Batches	Action	Class	Source
DEA-BW-2026-0004	04 Sept 2026	BW	Clarification On Medical Devices And Laboratory Equipment Currently Out Of Regulatory Scope For Import Control	none published	Guidance	Unclassified	Tier 1 · Regulator-published
DEA-BW-2026-0003	03 Sept 2026	BW	BoMRA CEO Engages Key Veterinary Industry Stakeholders On New Medicines And Related Substances Act And Draft Regulations	none published	Guidance	Unclassified	Tier 1 · Regulator-published
DEA-BW-2026-62509537	14 Jul 2026	BW	Risk of Acute Pancreatitis, Including Necrotizing and Fatal Cases, Associated with GLP‑1 Receptor Agonists and Dual GLP‑1/GIP Receptor Agonists.	none published	Safety communication	Unclassified	Tier 1 · Regulator-published
DEA-BW-2025-84824385	19 Feb 2025	BW	Tegretol Oral Suspension, limitation of use in neonates	none published	Safety communication	Unclassified	Tier 1 · Regulator-published
DEA-BW-2025-64375315	19 Feb 2025	BW	Hydrochlorothiazide – Risk Of Non Melanoma Skin Cancer ( Basal Cell Carcinoma, Squamous Cell Carcinoma)	none published	Safety communication	Unclassified	Tier 1 · Regulator-published
DEA-BW-2024-40097129	29 Feb 2024	BW	Risk of serious side effects with medicines containing pseudoephedrine	none published	Safety communication	Unclassified	Tier 1 · Regulator-published
DEA-BW-2024-39685589	28 Feb 2024	BW	Safety Concern- Acute Interstitial Nephritis asscoiated with Proton Pump Inhibitorss	none published	Safety communication	Unclassified	Tier 1 · Regulator-published
DEA-BW-2023-44412401	18 Apr 2023	BW	Pholcodine consumption increases the risk of perioperative anaphylaxis to neuromuscular blocking agents	none published	Safety communication	Unclassified	Tier 1 · Regulator-published
DEA-BW-2023-54496821	05 Apr 2023	BW	Pholcodine DHCP Letter	none published	Safety communication	Unclassified	Tier 1 · Regulator-published
DEA-BW-2023-20632138	13 Mar 2023	BW	Bedaquiline-containing regimenscardiac adverse events	none published	Safety communication	Unclassified	Tier 1 · Regulator-published
DEA-BW-2023-10424004	13 Mar 2023	BW	Suspected Adverse Drug Reactions of Angiotensin 11 converting enzyme inhibitors reported to BoMRA	none published	Safety communication	Unclassified	Tier 1 · Regulator-published
DEA-BW-2022-36212289	30 Mar 2022	BW	Subcutaneous Vasculitis Associated With Metformin & Vildagliptin	none published	Safety communication	Unclassified	Tier 1 · Regulator-published
DEA-BW-2022-76167636	01 Feb 2022	BW	Covid-19 vaccines signals new	none published	Safety communication	Unclassified	Tier 1 · Regulator-published

Published by BOMRA but not an action against a product: draft regulations, import requirements, and safety signals about an active substance or a class of medicines rather than a particular pack. They are held to the same standard as everything else here — the source is archived, the verification tier is shown — and they are kept off the register because a batch search cannot answer a question about a whole drug class.

Acted on elsewhere, relevant here

Cross-border

Reference	Date	Country	Product	Batches	Action	Class	Source
DEA-RW-2024-0088	12 Apr 2024	RW	Benylin	329304	Recall	Class I	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

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.