Atorvastatin Calcium Tablets — Class II drug recall D-1047-2020
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2020-03-25, distributed nationwide. Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Ca
| Recall number | D-1047-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2020-03-09 |
| Classified | 2020-03-19 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2021-02-09 |
| Distributed | Nationwide (US) |
| Quantity | 1,416 bottles |
| Reason classes | foreign material |
| 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 | AA33617 |
| Expiration dates | 2021-03 |
Product
Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05
Reason for recall
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
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-1047-2020. 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.