Recalls / Class I
Class ID-0488-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
- Brand name
- Sulfamethoxazole And Trimethoprim
- Generic name
- Sulfamethoxazole And Trimethoprim
- Active ingredients
- Sulfamethoxazole, Trimethoprim
- Route
- Oral
- NDCs
- 65162-271, 65162-272
- FDA application
- ANDA076899
- Affected lot / code info
- Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Why it was recalled
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Recalling firm
- Firm
- Amneal Pharmaceuticals, LLC
- Manufacturer
- Amneal Pharmaceuticals LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 400 Crossing Blvd Fl 3, Bridgewater, New Jersey 08807-2863
Distribution
- Quantity
- 6396 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-06-02
- FDA classified
- 2025-06-23
- Posted by FDA
- 2025-06-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0488-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.