An HSA product recall asks five things of an importer or wholesaler. Stop supplying the batch. Quarantine every unit you hold. Give HSA and the recalling company an accurate customer list. Send each customer a Dear Purchaser Letter. Then reconcile what came back against what you shipped. The deadlines are short, so the work depends on records you already keep.
Who runs a product recall in Singapore?
The Health Sciences Authority (HSA) regulates therapeutic products under the Health Products Act. Its defect reporting and recall page states that product registrants, manufacturers, importers and suppliers are responsible for the safety, quality and efficacy of their products. It links to guidance on product defect reporting and recall procedures, dated 28 January 2026.
The recall is usually started by the product registrant or the licensed importer. A wholesaler is then asked to act on it. Section 7 of HSA's Guidance Notes on Good Distribution Practice (GUIDE-MQA-013, December 2023) still expects every licensed dealer to meet these requirements:
- A written emergency plan for urgent recalls and a procedure for non-urgent ones
- A named person or committee to coordinate recalls
- A final report that reconciles delivered and recovered quantities
- A regular check that the recall arrangements actually work
What are the recall classes and deadlines?
HSA's recall products page sets these timelines. They exclude Sundays and public holidays.
| Action | Class 1 (critical) | Class 2 (non-critical) |
|---|---|---|
| Definition (summarised) | Defect may reasonably lead to serious adverse health consequences or death | Defect may cause temporary or reversible effects, or serious harm is remote |
| Notify HSA | No later than 24 hours before the recall starts | No later than 24 hours before the recall starts |
| Dear Purchaser Letter issued | Within 1 day of the recall starting | Within 3 days of the recall starting |
| Recall completed | Within 1 week, unless otherwise justified | Within 3 weeks, unless otherwise justified |
| Certificate of destruction | Within 3 months after completion | Within 3 months after completion |
A Class 1 recall gives you one working day to identify and write to every customer. You cannot do that by searching invoice PDFs.
What recall levels does HSA use?
The level decides how far down the supply chain the recall goes:
- Wholesale level: products are recovered from wholesalers and distributors only. This is used where the risk is lowest.
- Retail level: products are recovered from hospitals, pharmacies, clinics, healthcare practitioners, nursing homes and retailers such as supermarkets.
- Consumer level: products are recovered from everyone, including patients, and a media announcement may be needed.
Under the January 2026 guidance, a company must notify HSA immediately once it decides to start a consumer-level recall. Law firm Baker McKenzie's February 2026 summary reports two other changes. The guidance says more about what Dear Purchaser and Dear Healthcare Professional letters must contain. It also states that retrieving expired, non-defective stock is not a recall.
What should a wholesaler do step by step?
- Confirm the scope. Record the product name, registration number, strength, pack size, batch numbers and expiry dates in the notice, and the recall class and level. If no batches are named, treat all batches as affected until the recalling company confirms otherwise.
- Block the batch in your system. No sales order, delivery order, invoice or transfer should be able to pick it. GDP section 7.3 says recalled products must not be mixed with saleable stock.
- Quarantine physical stock. Move every unit to a labelled recall location with restricted access. Keep cold-chain items at their labelled temperature until disposal is decided.
- Stop goods in transit. Check picked, packed and out-for-delivery orders for the batch.
- Build the customer list. Trace every outbound document that shipped the batch, including samples, bonus stock and branch transfers. Export it as a spreadsheet, the format HSA asks for.
- Send the Dear Purchaser Letter. Send it within the class deadline. Record how and when each letter went out, and ask for acknowledgement.
- Receive returns against the original document. Log returns by customer and batch, and keep them in quarantine, never in saleable stock.
- Reconcile and report. Compare quantity received with quantity shipped, returned and still held. Explain any gap. Give the figures to the recalling company for its Product Recall Completion Form.
- Close out. File the destruction certificate or return-to-supplier documents with the recall record.
What records should you keep for a recall?
GDP section 5.6 sets out the distribution record. It should state the product name, transaction date, invoice or delivery order number, purchaser or supplier name and address, batch number, expiry date, quantity received or sold, and stock balance. A recall file should add:
| Record | Why HSA or the registrant needs it |
|---|---|
| Recall notice, class and level | Shows which deadlines applied |
| Customer list per batch (spreadsheet) | HSA asks for it in electronic spreadsheet format |
| Dear Purchaser Letters with send dates and acknowledgements | Shows that letters went out within 1 or 3 days |
| Returns log per customer and batch | Feeds the reconciliation of delivered against returned quantities |
| Reconciliation report | Required on completion, together with the completion form |
| Certificate of destruction | Due within 3 months after completion |
| Audit trail of stock status changes | Shows who placed and released holds, and when |
GDP section 5.7 says documents must be kept as long as the law requires and be easy to retrieve. Confirm the retention period for your licence with HSA.
How can you prove your recall process works?
GDP section 7.8 says recall arrangements should be evaluated regularly. The usual way to do this is a mock recall:
- Pick a real batch you have shipped to several customers.
- Start a timer and produce the full customer list with quantities.
- Check the list against the stock ledger: received minus shipped should equal stock on hand.
- Record the time taken and any gaps, and fix them through your corrective and preventive action (CAPA) process.
If the trace takes more than an hour, a Class 1 deadline is at risk.
How Asli Pharma ERP helps
Asli Pharma ERP records batch and expiry at goods receipt, and GS1 DataMatrix scanning can fill both in. It traces each batch from supplier to every customer. Its recall workflow puts the batch on hold, blocks it from sales, lists every customer and quantity, and generates customer notice letters and a close-out reconciliation report. Every step is kept in an audit trail. Recall timers set to HSA's Class 1 and Class 2 deadlines are on our roadmap and are not available yet, so track those dates in your recall SOP for now. Asli Pharma ERP supports GDP record-keeping. It does not make a company compliant; HSA assesses the company, not its software.
Frequently asked questions
What are the HSA recall classes?
HSA uses two classes for therapeutic products. Class 1 covers a critical defect that may reasonably lead to serious adverse health consequences or death. Class 2 covers a non-critical defect that may cause temporary or reversible health effects, or where serious consequences are remote.
How quickly must a Class 1 recall be completed?
HSA's recall page states that the Dear Purchaser Letter should be issued within 1 day of the recall starting and the recall completed within 1 week, unless otherwise justified. The day counts exclude Sundays and public holidays. For Class 2, the figures are 3 days and 3 weeks.
Does a wholesaler have to notify HSA itself?
The company initiating the recall, usually the product registrant or the licensed importer, must notify HSA no later than 24 hours before the recall starts. The HSA Guidance Notes on Good Distribution Practice also say the local regulatory authority should be informed of all product recalls, so a wholesaler should confirm who is notifying HSA and keep evidence of it.
What format does HSA want the customer list in?
HSA asks for the list of customers supplied with the affected batches in an electronic spreadsheet format. Include customer name, address, contact, invoice or delivery order number, date, batch number and quantity for every delivery.
Is taking back expired stock a recall?
No. HSA's product defect reporting and recall guidance dated 28 January 2026 states that retrieving expired products that are not defective, or retrieving a small quantity for investigation, is not treated as a recall.