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Famodine Tablet 20mg Recalled Due to Assay Test Result

Favicon for www.hsa.gov.sg HSA Singapore Announcements
Filed March 24th, 2026
Detected March 25th, 2026
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Summary

The Health Sciences Authority (HSA) Singapore has initiated a retail-level recall of Famodine Tablet 20mg (famotidine) due to out-of-specification assay test results. The affected batch (232218) must be stopped from supply and returned to the company.

What changed

The Health Sciences Authority (HSA) Singapore has issued a Class 2, retail-level recall for Famodine Tablet 20mg (famotidine), batch number 232218. The recall is due to out-of-specification results for the assay test, indicating a potential quality defect. While this does not necessarily mean the product is unsafe or ineffective, it fails to meet stringent regulatory standards.

Hospitals, clinics, and pharmacies are instructed to immediately stop supplying the affected batch and return any remaining stock to Duopharma (Singapore) Pte Ltd. This action ensures that registered therapeutic products in Singapore maintain high quality standards.

What to do next

  1. Stop supplying Famodine Tablet 20mg, batch 232218.
  2. Return remaining stocks of the affected batch to Duopharma (Singapore) Pte Ltd.

Source document (simplified)

Recall of Famodine Tablet 20mg (Famotidine)

Retail-level recall of Famodine Tablet 20mg, containing famotidine, due to an out-of-specification test result for assay.

| Date of Recall: | 24 Mar 2026 |
| Product: | Famodine Tablet 20mg |
| Active Ingredient: | Famotidine |
| Product Category: | Therapeutic Product |
| Registration Number: | SIN09129P |
| Batch No.: | 232218 |
| Class of Recall: | 2 |
| Level of Recall: | Retail |
| Local Company: | Duopharma (Singapore) Pte Ltd |
| Description of Issue: | Out-of-specification results |
| Recall Instructions: | Hospitals, clinics, pharmacies:
Stop supplying the affected batch and return the remaining stocks to the company. |
Note:

The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. These product recalls may be conducted on a company’s own initiative or upon HSA’s request to remove products where there are issues with quality, safety or efficacy.

When a recall is initiated, it does not necessarily imply that a product is considered unsafe or is inefficacious. A recall can also be initiated to remove products with quality defects that does not impact safety or efficacy from the market so as to ensure that products registered in Singapore continue to meet the stringent regulatory standards stipulated by HSA.

Not all recalls will lead to press releases. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press release to inform members of public.

Class of recall

A recall is classified as Class 1 or Class 2 depending on the potential hazard of the issue.

  • Class 1: For recalls of products with issues that can potentially **** cause serious adverse health outcomes or death.
  • Class 2: For recalls of products with issues that would not likely cause serious adverse health outcomes.

Level of recall

The level of product recall will depend on the potential hazard of the affected product, extent of distribution and whether other mitigating measures can be taken to address the issue.

  1. Consumer level: Affected product or batch(es) recalled from patients and consumers as well as wholesale suppliers, retail suppliers, hospitals, clinics and pharmacies.
  2. Retail level: Affected product or batch(es) recalled from retail suppliers, hospitals, clinics and pharmacies as well as wholesale suppliers.
  3. Wholesale level: Affected product or batch(es) recalled from wholesale suppliers.

Healthcare professional, Therapeutic Products Published:

26 Mar 2026

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
HSA
Filed
March 24th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
SIN09129P

Who this affects

Applies to
Healthcare providers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Product Recall Quality Control
Geographic scope
Singapore SG

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
GxP
Topics
Product Safety Quality Control

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