The South African Health Products Regulatory Authority (SAHPRA) believes in keeping the public (consumers), industry and healthcare professionals informed on essential emerging medicine updates by publishing safety alerts, recalls, media releases and other advice related to medicines in the market.
How does SAHPRA enforce a recall?
SAHPRA enforces a recall when a product supplied in South Africa has a problem or potential problem. Enforcing a recall is the most effective way to protect the public from a potentially harmful medicine/medical product.
- Medicines recalls are usually voluntary and led by the manufacturer who acknowledges the problem and takes corrective action instead of waiting for SAHPRA to enforce its regulatory authority.
- Recall actions can vary based on the type of medical product, and the scale or scope the problem poses to public health and safety. Decisions may be to stop using a medication immediately or the medication may still be safe to continue use; healthcare professionals and patients will be duly alerted to the problem.
- In addition, after assessment of the risk to the public, SAHPRA publishes an alert through our digital platforms (via website and, social media channels), including broadcasts through TV and radio interviews.
Alerts informs public and healthcare professionals about the problem regarding the medicine/product, what to do and how to safely discard it, and also on use of unaffected batches/alternate product.
Furthermore, the recall of a particular batch or batches of a product from the market may be occasioned either following notification of:
- A track of market quality defect of a product
- Serious reports of adverse reactions not included in the package insert and unacceptable frequency of an adverse event
- A detected fraudulent product
- Cancelation of registration,
- Selling of medicines illegally in South Africa
- An error on the label or package insert of the product or any problem identified by the HCR that may present a hazard to public health.