The Recall Desk
ModerateFDA (Drugs)·D-0624-2025·Announced 2025-09-17

Antibiotic Drug Tablets Recalled Due to Microbial Contamination in Packaging

A lot of sulfamethoxazole-trimethoprim tablets is being recalled due to discovery of a micro-organism 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 micro-organism was detected in packaging material, not on the tablets themselves, representing a potential rather than realized contamination risk.

Plain-English summary

The FDA is recalling Sulfamethoxazole and trimethoprim 800 mg/160 mg double strength tablets (Lot N02309, expiration date 03/31/2027) due to detection of a micro-organism in auxiliary packaging material. The packaging material was supplied by Amneal Pharmaceuticals LLC. No micro-organism was detected on any of the tablets themselves.

The affected product was distributed nationwide by Major Pharmaceuticals (The Harvard Drug Group LLC), located in Indianapolis, Indiana, under the brand name Sulfamethoxazole and Trimethoprim.

The FDA has classified this as a Class II recall.

The recalled product

Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Brand
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Manufacturer
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Category
Drug
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 (2)

  • Lot # N02309
  • Exp 03/31/2027

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · SULFAMETHOXAZOLE AND TRIMETHOPRIM

Same category