Amlodipine besylate and Atorvastatin calcium tablets — Class III drug recall D-1146-2015
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2015-06-24, distributed nationwide. Subpotent drug
| Recall number | D-1146-2015 |
|---|---|
| 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 | 2015-05-06 |
| Classified | 2015-06-18 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-03-31 |
| 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 | C402439 |
Product
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
Reason for recall
Subpotent drug
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-1146-2015. 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.