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Amneal Pharmaceuticals, LLC

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Class I

  • The FDA’s most serious category — a reasonable probability of serious harm or death.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Check with your pharmacist Filed 2025-06-18

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

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.

Check these codes: Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027

6396 bottles · distributed nationwide in the usa Recall D-0488-2025 on FDA.gov ↗
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