Ranitidine Capsules 300 mg — Class II drug recall D-0648-2020
Terminated recall by Appco Pharma LLC, reported 2020-01-15. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
| Recall number | D-0648-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Appco Pharma LLC, Piscataway, NJ, United States |
| Recall initiated | 2020-01-07 |
| Classified | 2020-01-07 |
| Reported by FDA | 2020-01-15 |
| Terminated | 2020-04-24 |
| Quantity | 1,632 bottes |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 62559-0691-30 |
| Lot numbers | 1905227UE, 1905228UE, APR-2021 |
Product
Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
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-0648-2020. 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.