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

Prescription antibiotic tablets recalled due to packaging contamination

Amneal Pharmaceuticals recalls Sulfamethoxazole and Trimethoprim tablets nationwide due to microbial contamination found in packaging material. No contamination was detected on the tablets themselves.

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: This is an FDA Class II recall with no reported illnesses or injuries. The contamination was detected in packaging material only, with no microorganism found on the tablets themselves, qualifying as low-risk contamination in a precautionary recall.

Plain-English summary

Amneal Pharmaceuticals, LLC is recalling specific lots of Sulfamethoxazole and Trimethoprim Tablets USP 800mg/160mg (Double Strength) distributed nationwide in the USA. Approximately 60,072 100-count bottles and 73,054 500-count bottles are affected.

The recall was initiated after a microorganism was detected in a specific lot of auxiliary polyester coil material used in product packaging. However, the FDA and manufacturer confirmed that no microorganism was detected on any of the tablets themselves. The contamination is limited to the packaging material.

Affected product lots include 100-count bottles (AM240173, AM240680, AM240921, AM241191) and 500-count bottles (AM240176, AM240177, AM240301, AM240300, AM240676, AM240677, AM240678, AM240679, AM240922, AM240923, AM240924, AM240925, AM241086, AM241087, AM241088), with expiration dates ranging from January 31, 2027 through August 31, 2027.

Consumers who have purchased these medications should not discard them but should contact their pharmacist or healthcare provider for guidance. Those with questions can contact Amneal Pharmaceuticals for further instructions regarding the recalled lots.

The recalled product

Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Brand
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Manufacturer
Amneal Pharmaceuticals, LLC
Category
Drug — Prescription Antibiotic
Hazard
  • microbial-contamination

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.

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