Atorvastatin Calcium Tablets — Class III drug recall D-0153-2020
Terminated recall by Apotex Inc., reported 2019-11-06, distributed in IL, MS, NJ, OH, TX. Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Cal
| Recall number | D-0153-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., North York, Canada |
| Recall initiated | 2019-10-22 |
| Classified | 2019-10-28 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2026-02-19 |
| Distributed | IL, MS, NJ, OH, TX |
| Quantity | 1,968 bottles |
| NDC | 60505-2578, 60505-2578-00, 60505-2578-03, 60505-2578-05, 60505-2578-07, 60505-2578-08, 60505-2578-09, 60505-2579, 60505-2579-00, 60505-2579-03, 60505-2579-05, 60505-2579-07, 60505-2579-08, 60505-2579-09, 60505-2580, 60505-2580-00, 60505-2580-03, 60505-2580-05, 60505-2580-07, 60505-2580-08, 60505-2580-09, 60505-2671, 60505-2671-00, 60505-2671-03, 60505-2671-05 and 3 more |
| Lot numbers | RC5439 |
| Expiration dates | 2022-03 |
Product
Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8
Reason for recall
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 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-0153-2020. 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.