The Recall Desk
SevereFDA (Drugs)·D-1535-2020·Announced 2020-09-02

Aurobindo Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Metal Wire

Aurobindo Pharma USA Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim tablets because of reports of metal wire in the tablets.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the presence of foreign metal wire in oral tablets poses a risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

Aurobindo Pharma USA Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle. The recall involves 5,748 bottles distributed nationwide in the U.S. The affected lots are STSD19109-A with an expiration date of 05/31/2022, and SP1D19083AA3 and SP1D19084AA3 with an expiration date of 08/31/2022. The product is identified by NDC 65862-420-05.

The recall was initiated because the firm received product complaints regarding the presence of metal wire in the tablets. This is an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this medication.

The recalled product

Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Brand
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Affected units
5,748

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 (5)

  • Lot #s: STSD19109-A
  • Exp. 05/31/2022
  • SP1D19083AA3
  • SP1D19084AA3
  • Exp. 08/31/2022.

Distribution

Distributed nationwide across the United States.