The Recall Desk
ModerateFDA (Drugs)·D-0615-2025·Announced 2025-09-10

Sulfamethoxazole and trimethoprim tablets recalled over micro-organism on packaging coil

Amneal sulfamethoxazole and trimethoprim double strength tablets are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers precautionary recalls; the contamination was found on a packaging component and the notice states no micro-organism was detected on any tablets.

Plain-English summary

Sulfamethoxazole and Trimethoprim Tablets, USP 800 mg/160 mg, double strength and available on prescription only, in 100-count bottles under NDC 65162-272-10 and 500-count bottles under NDC 65162-272-50, manufactured by Amneal Pharmaceuticals Pvt. Ltd., are being recalled. Affected lots include AM240173 expiring 01/31/2027, AM240680 expiring 05/31/2027, AM240921 expiring 06/30/2027 and AM241191, with the full list in the recall notice. The recall covers 60,072 100-count bottles and 73,054 500-count bottles distributed nationwide.

The recall was issued for the presence of a foreign substance: a specific lot of auxiliary polyester coil used in product packaging was found to contain a micro-organism. The notice states that no micro-organism was detected on any tablets. The FDA classified the action as Class II.

Patients should check the lot number on their bottle against the recall and should speak to their pharmacist about a replacement supply before stopping a prescribed antibiotic.

The recalled product

Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Brand
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Manufacturer
Amneal Pharmaceuticals, LLC
Category
Drug — Antibiotic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot a) AM240173
  • Exp Date 01/31/2027
  • AM240680
  • Exp Date 05/31/2027
  • AM 240921
  • Exp Date 06/30/2027
  • AM241191
  • Exp Date 08/31/2027. Lot b) AM240176
  • AM240177
  • AM240301
  • AM240300
  • Exp Date 02/28/2027
  • AM240676
  • AM240677
  • Exp Date 04/30/2027
  • AM240678
  • AM240679
  • Exp Date 05/30/2027. AM240922
  • AM240923
  • AM240924

UPCs (2)

  • 0365168211102
  • 0365162272109

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Amneal Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same brand · SULFAMETHOXAZOLE AND TRIMETHOPRIM

Same manufacturer · Amneal Pharmaceuticals, LLC

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Same hazard · packaging contamination

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