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

Major Pharmaceuticals antibiotic cartons recalled over micro-organism on packaging coil

Sulfamethoxazole and Trimethoprim double strength unit dose cartons from Major Pharmaceuticals are recalled because a micro-organism was found on a lot of packaging coil. No micro-organism was detected 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, USP, 800 mg/160 mg, double strength, in 100-tablet unit dose blister packs (10x10) per carton and available on prescription only, packaged and distributed by Major Pharmaceuticals of Indianapolis, Indiana, NDC 0904-2725-61, is being recalled. The affected product is lot N02309 with an expiry of 03/31/2027, distributed nationwide.

The recall was issued for the presence of a foreign substance: a specific lot of auxiliary polyester coil used in product packaging by the manufacturer, Amneal Pharmaceuticals LLC, 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 carton 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
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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 (2)

  • Lot # N02309
  • Exp 03/31/2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 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 2 products in this recall →

Related recalls

Same brand · SULFAMETHOXAZOLE AND TRIMETHOPRIM

Same manufacturer · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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Same hazard · packaging contamination

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