Atorvastatin Calcium Tablets — Class II drug recall D-0878-2018
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2018-06-27, distributed nationwide. Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreig
| Recall number | D-0878-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2018-05-30 |
| Classified | 2018-06-18 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2020-12-14 |
| Distributed | Nationwide (US) |
| Quantity | 6,397 bottles |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 00355111124900 |
| NDC | 55111-0124, 55111-0124-05, 55111-0124-30, 55111-0124-60, 55111-0124-90 |
| Lot numbers | T800064 |
| Expiration dates | 2019-12 |
Product
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900
Reason for recall
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
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-0878-2018. 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.