Amneal Pharmaceuticals, LLC drug recall: Sulfamethoxazole and Trimethoprim Tablets
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96985
- Recall initiated
- Jun 2, 2025
- Classified by FDA
- Jun 23, 2025
- Posted in Enforcement Report
- Jun 18, 2025
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Firm location
- Bridgewater, NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Press Release
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jun 2, 2025. FDA classified it 21 days later, on Jun 23, 2025. Distribution reported by FDA: Nationwide in the USA Amneal Pharmaceuticals, LLC has 16 recalls in our records.
Recalled products (1)
D-0488-2025 Class I Ongoing
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.
Codes / lots: Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Quantity: 6396 bottles
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 96985
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.