Recall products
Find out about information required, process and timelines to recall products.
Last updated 13 March 2026
When to initiate a product recall
When a defective product is considered to present a risk to the intended user or public health, HSA may require company to remove it from the market by recalling the affected batches or all batches of the product in extreme cases.
Company may also initiate a product recall for other reasons such as commercial reasons.
Product recall classification
The classification of a product recall will depend on the severity of the defect and its impact on a person's health.
Class 1 recall
A Class 1 recall involves the use or exposure to a product with a critical defect that may reasonably lead to serious adverse health consequences or death.
Class 2 recall
A Class 2 recall involves the use or exposure to a product with a non-critical defect that results in either one of the following scenarios:
Temporary or medically reversible adverse health consequences.
Remote probability of serious adverse health consequences.
Level of recall
The level of product recall describes the action required based on the extent of distribution of the affected product and potential hazard to public health.
Consumer level
Usually initiated when the risk to patients or consumers is assessed to be unacceptable, and where the product is directly supplied to consumers.
All wholesale and retail supply of the affected products or batches should be suspended.
Affected products or batches are to be recalled from all wholesale and retail distributors as well as patients/consumers who had been supplied with the affected products or batches.
Where necessary, the recall notification to consumers may need to be done via announcement on mass media such as press announcement, newspaper notification, television and/or radio (e.g. recall of a General Sales List medicine where it is not possible to contact patients/consumers who had been supplied with the affected products or batches, or recall of a product that had been widely supplied to consumers/patients).
Retail level
Usually initiated when the risk to patients or consumers is assessed to be moderate to high.
All wholesale and retail supply of the affected products or batches should be suspended.
Affected products or batches are to be recalled from all wholesale and retail distributors including:
Restructured and private hospital pharmacies.
Wholesale distributors
Retail pharmacies.
Medical, dental and other healthcare practitioners' establishments.
Community hospitals, nursing homes and other related institutions.
Other retail outlets, such as health food stores and supermarkets.
Wholesale level
Usually initiated when the risk to patients or consumers is assessed to be low or where other measures can be taken to mitigate the risk e.g. visual inspections or other interventions by healthcare professionals before supply to patients, or in situations to prevent disruption in supply of a critical product.
All wholesale supply of the affected products or batches should be suspended. Affected products or batches are to be recalled from:
All wholesalers.
All distributors.
All third-party logistics providers holding product to distribute to retailers etc.
The recalled products or batches should be segregated in a secured area before the implementation of follow-up actions e.g. destruction of the products.
When to notify HSA on the intended recall
Company does not need to seek approval from HSA for initiating the recall but must notify HSA of the intended recall no later than 24 hours (excluding Sundays and public holidays) before the start of the intended recall i.e. issuance of a notice to the customers or public.
Recall timelines
List of recall timelines
Recall steps | Class 1 recall | Class 2 recall |
|---|---|---|
Notify HSA | No later than 24 hours* prior to the start of the intended recall. | No later than 24 hours* prior to the start of the intended recall. |
Issue Dear Purchaser Letter | Within 1 day* of recall commencement | Within 3 days* of recall commencement |
Issue Dear Healthcare Professional Letter | Where required, within 1 day* of recall commencement | Where required, within 3 days* of recall commencement |
Complete recall process | Within 1 week, unless otherwise justified | Within 3 weeks, unless otherwise justified |
*excluding Sundays and public holidays.
Product recall process
Stages of product recall process
Stages | Details |
|---|---|
Initiate recall | Company initiates a product recall as a result of reports of product defects from healthcare professionals and the public. Company provides a list of supplied customers in an electronic spreadsheet format (e.g. Microsoft Excel file) to HSA. |
Follow recall process and procedures | The requirements for the management of recall, including the types of records that should be kept for supply chain traceability, as well as sale and distribution records of wholesale or retail supply, are described in the Health Products (Cell, Tissue and Gene Therapy Products) Regulation. The PIC/S GMP Guide and/or HSA Guidelines on Good Manufacturing Practice For Cell, Tissue And Gene Therapy Products stipulate the establishment of written procedures which will be implemented as the need for a recall by the manufacturer arises. HSA Guidance Notes on Good Distribution Practice also stipulates the establishment of written recall procedures by the importers and wholesalers of CTGTP. |
Notify stakeholders of recall actions | Company communicates the presence of defects and the recall actions to be taken to the customers through appropriate means. A Dear Purchaser Letter is a letter issued by the company to its purchasers (such as hospitals, clinics, retail stores) to alert them to the administrative or logistic matters related to the product recall. The Dear Purchaser Letter should include (but not limited to) the following information:
A Dear Healthcare Professional Letter is issued to notify the healthcare professionals about important new or updated information regarding major safety, quality and efficacy concerns related to the use of a product that presents potential risks to patients or public health. Company can discuss with HSA on the issuance of the Dear Healthcare Professional Letter. The Dear Healthcare Professional Letter should include (but not limited to) the following information:
|
Issue press release | Company may be required to issue a mass media announcement (e.g. newspaper advertisement) to notify the public on the recall in a timely manner, if deemed necessary e.g. critical defects. |
Complete recall | Company must keep HSA informed of the progress of the recall action. Company should perform an effectiveness check to verify that the recall communication was received by the customers and that they understood and followed through the recall instructions. Company needs to furnish the Product Recall Completion Form upon completion of the product recall, together with a report of reconciliation of quantities of each affected batch (i.e. delivered and returned quantities). As part of the recall completion report, company updates HSA of the completion follow-up actions i.e. submit the certificate of destruction to HSA within 3 months from the completion of the recall. Prior approval for local destruction is not required. If any other actions are to be taken, specify them on the Product Recall Completion Form and they will be subjected to HSA’s approval. |
Reinstatement of supply | Corrective actions need to be performed to address the quality defect and carry out preventive actions to prevent recurrence of the defect in the future before reinstating supply of product. Quarantined stocks can only be released with HSA's concurrence, when it has been determined that there is no safety risk in the use of the product or after appropriate corrective actions had been taken to address the safety risk. |