Pharmaceutical Batch Recall in the UAE: A Distributor Guide

A batch recall in the UAE has five parts: stop selling the batch, quarantine every unit you hold, notify every customer who received it, retrieve and reconcile the returned stock, and send a completion report to the regulator. The speed of each step depends on one thing you control in advance: whether your records link each batch from the supplier's delivery to each customer invoice.

Who regulates medicine recalls in the UAE?

Federal oversight of medical products has moved from the Ministry of Health and Prevention (MOHAP) to the Emirates Drug Establishment (EDE). The EDE was created by Federal Decree-Law No. 28 of 2023. Federal Decree-Law No. 38 of 2024 sets the rules for medical products, pharmacists and pharmaceutical establishments.

The EDE publishes recall circulars on its legislations page. In January 2026, for example, it issued precautionary recall circulars for several infant formula products. MOHAP describes the handover of services on its transfer page.

Emirate health authorities also act on recalls. The Department of Health Abu Dhabi (DOH) has its own Policy for Quarantine and Recall of Medical Products (reference DOH/Policy/RIC/QRMP/2023, effective December 2023). If you supply facilities in several emirates, follow whichever authority issued the recall, and check each circular for its own instructions.

What are the recall classes?

The DOH policy uses three classes, in line with common international practice:

Class	DOH definition (summarised)	Recall report due (DOH policy)
Class I (Critical)	A dangerous or defective product that could cause serious health problems or death	Within 1 week, unless otherwise justified
Class II (Major)	A product that might cause a temporary health problem, or pose a slight threat of a serious nature	Within 3 weeks, unless otherwise justified
Class III (Minor)	Unlikely to cause an adverse reaction, but violates labelling or manufacturing regulations	Within 3 weeks, unless otherwise justified

Under the same policy, a recall is effective immediately once it is issued. Products that are deficient, or suspected to be, must be withdrawn and held from use until the investigation ends. In practice, a distributor should place a hold as soon as it learns of a credible problem, not only when a circular arrives.

What should a distributor do in the first hour?

The first hour decides how many units reach patients after the recall. Act on these steps at once:

Identify the exact scope. Record the product, strength, pack size, batch or lot numbers and expiry dates named in the notice. If the notice names a product without batches, treat all batches as in scope until the supplier or regulator confirms otherwise.
Block sales system-wide. Put the batch on hold so that no sales order, invoice, delivery note or stock transfer can pick it. A note on a whiteboard is not a block.
Stop goods in transit. Check deliveries that are picked, packed or on a vehicle, and bring back any cartons from the affected batch.
Quarantine physical stock. Move every unit to a labelled, segregated recall location. Keep cold-chain items in a 2–8°C recall area; a recalled vaccine still needs its temperature kept until disposal is decided.
Tell the supplier or marketing authorisation holder (MAH). Confirm you have received the notice, the quantities you hold, and your contact for the recall.

How do you build the customer notification list?

Run a forward trace: every outbound document that shipped the affected batch, with customer name, delivery address, quantity, date and document number. Include sales invoices, delivery notes, free samples, bonus or free-of-charge quantities and inter-branch transfers.

Then run a backward trace: which supplier delivery (goods receipt) brought the batch in, and on what date. The total received, minus the total shipped, should equal what you have in quarantine. Any gap needs explaining before you close the recall.

Send each customer a written notice that states the product, batch, expiry, reason for recall, the action required (stop dispensing, quarantine, return) and a named contact. Keep proof of sending and ask for acknowledgement. Chase non-responders by phone and log each call.

How should returned stock be handled?

Receive recalled returns against the original invoice so quantities reconcile per customer.
Keep returns in the recall location, never back in saleable stock.
Issue credit notes as agreed with the supplier. Medicines registered with the regulator are generally zero-rated for UAE VAT, so the credit note normally carries zero VAT, but it still needs to be a proper tax credit note.
Hold the stock until the supplier or regulator confirms whether it is to be returned, destroyed under supervision, or released.
Keep destruction certificates and return shipment documents with the recall file.

What goes in the recall close-out report?

Regulators and suppliers expect a reconciliation that accounts for every unit. A useful close-out report contains:

Recall reference, class, product and batch details, and the date the notice was received.
Quantity received from the supplier and the receipt document numbers.
Quantity shipped, per customer, with document numbers.
Quantity recovered from each customer, quantity held in your warehouse, and any shortfall with its explanation (for example, already dispensed to patients).
Dates each customer was notified and acknowledged.
Final disposition: returned to supplier, destroyed, or released after investigation.

Under the DOH policy, the marketing authorisation holder, vendor, supplier or authorised agent must complete the recall report within one week for Class I and within three weeks for Class II and III. Distributors usually feed their figures to the MAH, so have them ready well before those dates.

How does Tatmeen affect recalls?

Tatmeen, the UAE's pharmaceutical track-and-trace platform, records movements at pack level using GS1 identifiers. Its FAQs describe status change messages for events such as damage and loss. Where your products are serialised and reported to Tatmeen, keep the recall status of each pack consistent between your ERP or WMS and what you report. Check current Tatmeen guidance for how recalled stock should be reported.

How can you prepare before a recall happens?

Capture batch number and expiry at every goods receipt, and never allow a sale without a batch.
Record batches on free goods, samples and transfers as carefully as on invoices.
Write a recall procedure that names who decides, who blocks stock and who contacts customers, with backups.
Keep customer contact details current, including an after-hours number for pharmacies and hospitals.
Run a mock recall at least once or twice a year and time how long the forward trace takes.

How Asli Pharma ERP helps

Asli Pharma ERP records batch, manufacturing date and expiry at goods receipt and traces each batch from supplier to customer. Its recall workflow puts affected stock on hold, blocks it from sales, produces customer notices from the invoices that shipped the batch, and generates a close-out report. Stock status buckets (released, quarantine, rejected, damaged, returned, recall) keep recalled units out of saleable stock, and an audit trail records who did what.

Frequently asked questions

Who issues medicine recalls in the UAE in 2026?

Federal regulation of medical products moved from the Ministry of Health and Prevention (MOHAP) to the Emirates Drug Establishment (EDE), which publishes recall circulars on its website. Emirate-level health authorities such as the Department of Health Abu Dhabi also issue and enforce quarantine and recall actions in their emirate.

How fast must a recall report be completed?

Under the Department of Health Abu Dhabi policy for quarantine and recall of medical products (December 2023), Class I recall reports are due within one week and Class II and III reports within three weeks, unless otherwise justified. Check the specific circular, because the regulator can set its own deadline for a given recall.

Should a distributor wait for the recall circular before blocking stock?

No. Products identified or suspected to be deficient should be withdrawn and held from sale while the investigation runs. Putting the batch on hold costs little; shipping a batch that is later recalled costs far more.

What records does a distributor need to execute a recall?

You need batch-level records that link each receipt from a supplier to every sales invoice or delivery note that shipped that batch, with customer, quantity and date. Without that link you cannot produce an accurate customer list or reconcile what came back.

What is a mock recall?

A mock recall is a drill in which you pick a real batch and trace it forward to customers and back to the supplier within a set time, without actually recalling it. Running one or two a year shows whether your records and team can meet a real deadline.

How to run a pharmaceutical batch recall in the UAE