Sulfamethoxazole and Trimethoprim Tablets — Class II drug recall D-1535-2020
Terminated recall by Aurobindo Pharma USA Inc., reported 2020-09-02, distributed nationwide. Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in
| Recall number | D-1535-2020 |
|---|---|
| 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 | 2020-08-10 |
| Classified | 2020-08-21 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2024-06-28 |
| Distributed | Nationwide (US) |
| Quantity | 5,748 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 | SP1D19083AA3, SP1D19084AA3, STSD19109-A |
| Expiration dates | 2022-05-31, 2022-08-31 |
Product
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05.
Reason for recall
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
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-1535-2020. 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.