Why it was recalled
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0488-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jun 2, 2025
- FDA report date
- Jun 18, 2025
- Quantity
- 6396 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0488-2025, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96985
- Address
- 400 Crossing Blvd Fl 3
- Code information
- Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
- Postal code
- 08807-2863
- Report date
- Jun 18, 2025
- Product type
- Drugs
- Recall number
- D-0488-2025
- Classification
- Class I
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Product quantity
- 6396 bottles
- Reason for recall
- Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 2, 2025
- Initial firm notification
- Press Release
- Center classification date
- Jun 23, 2025