Sulfamethoxazole and Trimethoprim Tablets — Class II drug recall D-0719-2021
Terminated recall by Aurobindo Pharma USA Inc., reported 2021-08-18, distributed nationwide. Presence of Foreign Substance- Potential of metal contamination.
| Recall number | D-0719-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2021-07-07 |
| Classified | 2021-08-10 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 3,800 bottles |
| NDC | 65862-0419, 65862-0419-01, 65862-0419-05, 65862-0419-20, 65862-0419-99, 65862-0420, 65862-0420-01, 65862-0420-05, 65862-0420-20, 65862-0420-99 |
| Lot numbers | P1D19082AA3, P1D19085AA3 |
| Expiration dates | 2022-08 |
Product
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
Reason for recall
Presence of Foreign Substance- Potential of metal contamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0719-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.