Amlodipine Besylate Tablets — Class III drug recall D-0899-2023
Terminated recall by Lupin Pharmaceuticals Inc., reported 2023-07-19, distributed nationwide. Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study
| Recall number | D-0899-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2023-06-27 |
| Classified | 2023-07-07 |
| Reported by FDA | 2023-07-19 |
| Terminated | 2024-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 3,096 bottles |
| Reason classes | potency, specification failure |
| NDC | 68180-0233, 68180-0233-01, 68180-0233-02, 68180-0455, 68180-0455-01, 68180-0455-02, 68180-0719, 68180-0719-03, 68180-0719-09, 68180-0720, 68180-0720-03, 68180-0720-09, 68180-0721, 68180-0721-03, 68180-0721-09, 68180-0750, 68180-0750-09, 68180-0751, 68180-0751-03, 68180-0751-09, 68180-0751-17, 68180-0752, 68180-0752-03, 68180-0752-09 |
| Lot numbers | A102887 |
| Expiration dates | 2023-06 |
Product
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
Reason for recall
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
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-0899-2023. 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.