FDA Drug recall D-0719-2021
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, In…
- FDA Drug
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, In… by Aurobindo Pharma Usa, citing presence of Foreign Substance- Potential of metal contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0719-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-07 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
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
Presence of Foreign Substance- Potential of metal contamination.
Identifiers
| ndc | 65862-419-20 |
|---|---|
| ndc | 65862-419-01 |
| ndc | 65862-419-05 |
| ndc | 65862-419-99 |
| ndc | 65862-420-20 |
| ndc | 65862-420-01 |
| ndc | 65862-420-05 |
| ndc | 65862-420-99 |
| code_info | Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0719-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.