FDA Drug recall D-1535-2020
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo P…
- FDA Drug
- Class II
- terminated
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class II recall of Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo P… by Aurobindo Pharma Usa, citing presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1535-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-10 |
| Published | 2020-09-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
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
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
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 | Lot #s: STSD19109-A, Exp. 05/31/2022; SP1D19083AA3, SP1D19084AA3, Exp. 08/31/2022. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2024-12-25 · Aurobindo Pharma Usa - Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, D…
FDA Drug · Class II · 2024-12-11 · Aurobindo Pharma Usa - Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Di…
FDA Drug · Class II · 2024-12-11 · Aurobindo Pharma Usa
All Aurobindo Pharma Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1535-2020%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.