FDA Drug recall D-0263-2022
Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, Ea…
- FDA Drug
- Class III
- terminated
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class III recall of Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, Ea… by Aurobindo Pharma Usa, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0263-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-11-15 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
Product
Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05
Reason
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 65862-142-01 |
|---|---|
| ndc | 65862-142-05 |
| ndc | 65862-142-99 |
| ndc | 65862-143-01 |
| ndc | 65862-143-05 |
| ndc | 65862-143-99 |
| ndc | 65862-144-01 |
| ndc | 65862-144-05 |
| ndc | 65862-144-99 |
| ndc | 65862-145-01 |
| ndc | 65862-145-05 |
| ndc | 65862-145-99 |
| code_info | Batch QG0619030-A, exp 11/2022 |
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 · 2024-12-11 · 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-0263-2022%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.