The Recall Desk
ModerateFDA (Drugs)·D-0719-2021·Announced 2021-08-18

Sulfamethoxazole and Trimethoprim Tablets Recalled for Metal Contamination

Aurobindo Pharma USA Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) due to potential metal contamination in the product. The recall affects approximately 3,800 bottles distributed nationwide.

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 hazard is potential metal contamination, which presents a theoretical risk of harm. Per the rubric, Class II recalls with no reported hospitalization or injury reports, and where the risk is not from a high-risk pathogen or allergen, are typically scored as Moderate (2).

Plain-English summary

Aurobindo Pharma USA Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength in bottles of 500 tablets (NDC 65862-420-05) due to the presence of a foreign substance with potential metal contamination.

The affected product includes Batch SP1D19082AA3 and Batch SP1D19085AA3, with expiration date 08/2022. Approximately 3,800 bottles were distributed nationwide by Aurobindo Pharma USA Inc., located at 279 Princeton-Hightstown Road, East Windsor, NJ 08520.

Consumers who have this medication should stop taking it and contact their pharmacy or healthcare provider. Patients should not discontinue use without consulting their healthcare provider, as this is a prescription antibiotic used to treat bacterial infections. Anyone who has consumed this product and has concerns should seek medical attention.

This is a Class II recall issued by the U.S. Food and Drug Administration.

The recalled product

Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Brand
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Manufacturer
Aurobindo Pharma USA Inc.
Category
Drug — Antibiotic / Oral Tablet
Hazard
Affected units
3,800

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)

  • Batch SP1D19082AA3 & Batch SP1D19085AA3
  • Exp 08/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · SULFAMETHOXAZOLE AND TRIMETHOPRIM

Same manufacturer · Aurobindo Pharma USA Inc.

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Same hazard · metal contamination

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