Atorvastatin Calcium Tablets — Class II drug recall D-072-2013
Terminated recall by Ranbaxy Inc., reported 2012-12-05, distributed nationwide. Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain sma
| Recall number | D-072-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ranbaxy Inc., Princeton, NJ, United States |
| Recall initiated | 2012-11-09 |
| Classified | 2012-11-29 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2014-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 157,026 bottles |
| Reason classes | foreign material, specification failure |
| NDC | 63304-0827, 63304-0827-05, 63304-0827-90, 63304-0828, 63304-0828-05, 63304-0828-90, 63304-0829, 63304-0829-05, 63304-0829-90, 63304-0830, 63304-0830-05, 63304-0830-90 |
| Lot numbers | 2434265, 2434266, 2434824, 2434826, 2434827, 2434828, 2434829, 2434830, 2434831, 2436580, 2436725, 2436727, 2436729, 2437377, 2437380, 2437941, 2437943, 2437944, 2437949, 2437950, 2437955, 2437956, 2437957, 2440675 |
| Expiration dates | 2014-07-31, 2014-08-31 |
Product
Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05.
Reason for recall
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
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-072-2013. 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.