A recall is action taken to remove a specific medicine, or specific batches of it, from the supply chain because of a problem with the product. In South Africa recalls are handled by SAHPRA and published on its product recalls page, alongside a rapid alert system for urgent issues.
If a medicine you take is recalled, do not simply stop taking it. Many recalls are precautionary and concern a manufacturing or packaging issue rather than immediate danger to patients. For a medicine treating a serious condition, stopping abruptly can be more harmful than finishing the pack. Contact your pharmacist, who can tell you whether your batch is affected and arrange a replacement.
Quick answer: when and how to report a suspected side effect
What information to record
Recalls are usually batch-specific, so the batch number is the detail that matters. It is printed on the carton and often on the blister strip. Check it against the recall notice before assuming your pack is affected.
Where reporting fits into medicine safety
Recalls often begin with reports. A pattern of unexpected reactions or noticed defects can trigger the investigation that leads to one. See how to check for a medicine recall.
Who can report a side effect or adverse drug reaction?
What information to record
Anyone, including if you noticed the problem with the product rather than a reaction to it: tablets that look wrong, a broken seal, an unexpected smell, missing or damaged contents, or packaging that does not match. See reporting a medicine quality problem.
Where reporting fits into medicine safety
Keep the product rather than discarding it if a fault is suspected, since it may be needed for investigation.
What information should you collect before reporting?
What information to record
- Product name, strength, dose form
- Batch or lot number and expiry date
- Where and when you obtained it
- What is wrong with it, and whether anyone took it
- Any symptoms that followed
Where reporting fits into medicine safety
Photographs of the packaging and the batch number are useful and easy to take before anything is returned.
How to report through SAHPRA, Med Safety or the ADR form
What information to record
- SAHPRA online reporting via the reporting routes listed on SAHPRA’s health products vigilance page
- The Med Safety App
- The ADR and quality problem form
- Through a doctor or pharmacist, or the company marketing the product
SAHPRA also publishes information on recalls reporting and safety alerts.
Where reporting fits into medicine safety
Your pharmacy is usually the fastest practical route for a recalled pack, because they can check the batch, take the product back and supply a replacement in one visit.
What counts as a serious or unexpected side effect?
Red-flag symptoms
A reaction counts as serious when it results in death, threatens life, requires or prolongs hospital admission, causes lasting disability, causes a birth defect, or is otherwise medically important. Unexpected means it is not described in the approved product information.
Difficulty breathing, facial or throat swelling, chest pain, seizures or a blistering rash need emergency care. See serious medication side effects.
When to contact a doctor, pharmacist, or emergency service
Contact a pharmacist if you have taken a recalled product and feel well, and a doctor if you feel unwell. Do not stop a prescribed medicine for a serious condition without a replacement plan.
What happens after a report is submitted?
What information to record
Note the batch number before returning the pack, so you have a record of what you had.
Where reporting fits into medicine safety
Recalls are graded by how serious the risk is, which determines how far down the supply chain the recall reaches: some are limited to wholesalers and pharmacies, others extend to patients. See recalled medicines in South Africa and SAHPRA product recalls.
Medical Disclaimer: This content is for informational and educational purposes only and does not constitute medical diagnosis, prescription, or professional advice. Always read the patient information leaflet and consult a qualified doctor or pharmacist regarding any medicine or health concern.