AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only… — Class II drug recall D-0165-2020
Terminated recall by AVKARE Inc., reported 2019-11-06, distributed in CO, MO. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
| Recall number | D-0165-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2019-10-17 |
| Classified | 2019-10-28 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2020-10-21 |
| Distributed | CO, MO |
| Quantity | 1,351 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| UPC / GTIN / UDI-DI | 00342291736504 |
| NDC | 42291-0736-50 |
| Lot numbers | 17709, 18460, 19853, 22362, 22579 |
| Expiration dates | 2020-01-31, 2020-02-29, 2020-09-30, 2020-11-30 |
Product
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
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-0165-2020. 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.