Aurobindo Pharma Sulfamethoxazole and Trimethoprim Tablets Recall

Why it was recalled

Presence of Foreign Substance- Potential of metal contamination.

Product description

Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05

Lot numbers, UPCs & expiration codes

Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0719-2021
Classification: Class II
Status: Terminated
Recall initiated: Jul 7, 2021
FDA report date: Aug 18, 2021
Quantity: 3800 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Aurobindo Pharma USA Inc.

Original FDA data

Every field from FDA enforcement report D-0719-2021, exactly as published.

Show all FDA fields

City: East Windsor
State: NJ
Status: Terminated
Country: United States
Event ID: 88227
Address: 279 Princeton Hightstown Rd
Code information: Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022
Postal code: 08520-1401
Report date: Aug 18, 2021
Product type: Drugs
Recall number: D-0719-2021
Classification: Class II
Recalling firm: Aurobindo Pharma USA Inc.
Product quantity: 3800 bottles
Termination date: Oct 18, 2023
Reason for recall: Presence of Foreign Substance- Potential of metal contamination.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05
Distribution pattern: Nationwide
Recall initiation date: Jul 7, 2021
Center classification date: Aug 10, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0719-2021, published Aug 18, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.