Picture a Tuesday morning at a busy counter. A distributor’s representative hands over a letter: one batch of a product you stock is being recalled. Half a dozen customers are waiting, and two colleagues are already dispensing.
What you do in the next hour matters, and the rules say less about it than you might expect. The one thing they say clearly is this: once a product is under recall, no one may sell it, offer it or supply it. Regulation 4 of the 2015 recall regulations is blunt about that.
This guide walks through what the official documents require, what they leave to you, and how a pharmacy can fill the gaps. It covers the rules of the Tanzania Medicines and Medical Devices Authority (TMDA). Zanzibar has its own regulator, the Zanzibar Food and Drug Agency, and its arrangements are not covered here.
What the rules actually say
The regulations define a recall as removing specific batches of a medicine from the market because of problems with quality, safety or efficacy. The word to notice is “batches”. A recall rarely means the whole brand is unsafe, so reading the notice closely saves you from pulling stock you can legally keep selling.
Regulation 13 goes further. Nobody may sell, supply or even hold for sale products that are unfit. It also tells dealers how to keep unfit stock until it is disposed of: keep a register, store controlled medicines, anti-neoplastics, antibiotics and other hazardous products apart from each other, group items by dosage form, and mark the area in red with the words “Unfit for intended use” or “Hazifai kwa matumizi”. Breaking these rules is an offence under the parent Act.
TMDA’s recall guideline (third edition, October 2020) repeats the red-marked, separated storage. It also asks facilities to keep a register of unfit products showing the name, manufacturer, strength, dosage form, quantity and market value.
How the news reaches you
A recall can be started by TMDA, or by a manufacturer, registrant or marketing authorisation holder, who pays for it, according to TMDA’s recall page. The guideline sorts recalls into three classes by health risk, with maximum recall times of 14 days (Class I), 21 days (Class II) and 30 days (Class III). Those limits apply to the recall as a whole. The guideline sets no separate deadline for an individual pharmacy.
It also describes three depths of recall. At Level A, everyone in the supply chain and the patients themselves are told through media and letters. At Level B, public and private outlets and health facilities get urgent letters. At Level C, wholesalers and retailers hear from company representatives, or by phone or letter where distribution is known.
So your first word of a recall may come from a supplier’s representative, not a public notice. Treat that as a real notice, and ask for the product, batch and manufacturer details in writing.
What to do, step by step
The first and last steps below come from the regulations. The middle ones are recommended practice, built from the storage and record-keeping rules. Adapt them to your own premises.
1. Read the notice closely. Match the product name, strength, dosage form, batch number, manufacturing and expiry dates and manufacturer against what you hold. TMDA’s published recall lists show these same fields for each entry.
2. Stop selling straight away. Take the product off the shelf and block it in your dispensing or point-of-sale system, so a colleague on another shift cannot sell it by mistake. This is the step the regulations state outright.
3. Look everywhere. Check shelves, the back store, the fridge, dispensing trays, returns bins and any branch or van stock. Count what you find, note the batch numbers and record how much was already sold.
4. Quarantine it. Move affected units to a secured area marked in red, away from stock in use and from other types of unfit product, as the guideline describes.
5. Write it down. Enter the product, manufacturer, strength, dosage form and quantity in your register of unfit products. Keep a copy of the notice, the date and time you received it, and the name of the person who acted. If an inspector calls, this is your proof.
6. Leave disposal to the proper channel. Regulation 9 bars anyone from disposing of unfit products without applying to TMDA and getting approval. The guideline sets out the route: an application to the Director General with an itemised list, verification by an inspector, a certificate from the National Environment Management Council, supervised destruction and a certificate of destruction from TMDA. The owner pays the destruction costs.
There is also a financial reason to act early. When TMDA seizes stock instead of the owner surrendering it, the guideline adds a 25% fee on the market value.
7. Stay within the notice when patients ask. Customers who bought the product may want advice. Pass on what the notice says, and send questions about changing treatment to the prescriber. Never tell a patient to stop a prescribed medicine on your own judgement.
A recent example
On 23 June 2026, TMDA banned human medicines containing levamisole. According to Mfamasia’s report, pharmacies were told to stop handling, dispensing and selling them, set aside any remaining stock, inform patients and report suspected adverse reactions through the national pharmacovigilance system. Importers and distributors had 14 days to complete a recall.
The report does not say where pharmacies should return stock. That is a good reminder to confirm the return route with TMDA or your supplier on the day a notice arrives.
Where the rules go quiet
Neither the regulations nor the guideline gives pharmacies a time limit for quarantining stock, says how long records must be kept, or spells out the pharmacy’s own reporting duty after a notice arrives. The guideline defines a superintendent as the pharmacist in charge of a pharmacy business but gives that role no specific recall duties, and TMDA’s recall page does not say where individual notices are published.
Until that is clarified, a short written procedure covers most of the gap. Name who receives notices, who checks stock, where quarantined items go and who keeps the register. One page, shared with every member of staff including ADDO dispensers, is enough.
Quick takeaways
- A recalled product must not be sold or supplied, and unfit stock must not be held for sale.
- Recalls target named batches, so check batch details before pulling anything.
- Quarantine stock in a red-marked, separated area and log every unit.
- Disposal needs TMDA approval and supervised destruction, and the owner pays.
- A one-page procedure fills the gaps the regulations leave open.
