AVKARE Ranitidine Tablets — Class II drug recall D-0524-2020
Terminated recall by AVKARE Inc., reported 2019-12-04, distributed nationwide. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
| Recall number | D-0524-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2019-11-14 |
| Classified | 2019-11-26 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2021-10-27 |
| Distributed | Nationwide (US) |
| Quantity | 631,138 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 42291-0724-10, 42291-0724-18, 42291-0724-60 |
| Expiration dates | 2019-11-30, 2020-03-31, 2020-04-30, 2020-05-31, 2020-08-31, 2020-09-30, 2020-10-31, 2020-11-30, 2020-12-31, 2021-03-31, 2021-04-30, 2021-06-30 |
Product
AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
Reason for recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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-0524-2020. 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.