Clorazepate Dipotassium Tablets — Class II drug recall D-0491-2024
Ongoing recall by Aurobindo Pharma USA Inc., reported 2024-05-15, distributed nationwide. Discoloration: Dotted and yellow spots on tablets
| Recall number | D-0491-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2024-04-24 |
| Classified | 2024-05-08 |
| Reported by FDA | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 6,696 bottles |
| NDC | 13107-0282, 13107-0282-01, 13107-0282-05, 13107-0283, 13107-0283-01, 13107-0283-05, 13107-0284, 13107-0284-01 |
| Expiration dates | 2025-12-31 |
Product
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Reason for recall
Discoloration: Dotted and yellow spots on tablets
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-0491-2024. 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.