The Recall Desk
HighFDA (Drugs)·D-0625-2025·Announced 2025-09-17

FDA Recalls Antibiotic Drug Sulfamethoxazole and Trimethoprim for Packaging Contamination

The FDA is recalling a specific lot of Sulfamethoxazole and Trimethoprim due to presence of a micro-organism in the auxiliary polyester coil packaging material. No micro-organism was detected on the tablets themselves.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a micro-organism detected in product packaging material. Although no contamination was found on the tablets themselves and no illnesses have been reported, it represents a risk-of-harm situation. Per the rubric, recalls with no reported illnesses and theoretical hazards score at most 3.

Plain-English summary

The FDA is recalling a specific lot of Sulfamethoxazole and Trimethoprim (Double Strength, 800 mg/160 mg) tablets due to detection of a micro-organism in the auxiliary polyester coil used in product packaging. The affected lots are Bag: N02309A and N02309B with expiration date 03/31/2027; Inner blister Lot # N02309 with expiration date 03/31/2027. Importantly, no micro-organism was detected on any of the tablets themselves.

The recalled product was distributed nationwide throughout the United States. The product is an antibiotic used to treat bacterial infections and is available by prescription only. It is distributed by Cardinal Health, Dublin, OH 43017.

Consumers and healthcare providers who have this medication should not use the affected lots. Patients should contact their healthcare provider or pharmacist about alternative treatment options. The medication should be returned to the pharmacy where it was purchased or disposed of according to local regulations.

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
  • contamination
  • micro-organism

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 (3)

  • Bag: N02309A and N02309B
  • Exp Date: 03/31/2027
  • Inner blister: Lot # N02309

UPCs (1)

  • 0055154789509

Distribution

Distributed nationwide across the United States.

Related recalls

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