Amlodipine besylate and Atorvastatin calcium Tablets — Class III drug recall D-1377-2015
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2015-09-02, distributed nationwide. Subpotent Drug: Subpotent atorvastatin.
| Recall number | D-1377-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2015-08-13 |
| Classified | 2015-08-27 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2016-12-15 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| NDC | 43598-0313, 43598-0313-05, 43598-0313-30, 43598-0313-60, 43598-0313-90, 43598-0314, 43598-0314-05, 43598-0314-30, 43598-0314-60, 43598-0314-90, 43598-0315, 43598-0315-05, 43598-0315-30, 43598-0315-60, 43598-0315-90, 43598-0316, 43598-0316-05, 43598-0316-30, 43598-0316-60, 43598-0316-90, 43598-0317, 43598-0317-05, 43598-0317-30, 43598-0317-60, 43598-0317-90 and 30 more |
| Lot numbers | C404592 |
| Expiration dates | 2015-11 |
Product
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India
Reason for recall
Subpotent Drug: Subpotent atorvastatin.
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-1377-2015. 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.