Ranitidine Tablets — Class II drug recall D-0613-2020
Ongoing recall by Amneal Pharmaceuticals, Inc., reported 2019-12-18, distributed nationwide. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
| Recall number | D-0613-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals, Inc., Brookhaven, NY, United States |
| Recall initiated | 2019-11-22 |
| Classified | 2019-12-09 |
| Reported by FDA | 2019-12-18 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 65162-0254-10, 65162-0254-25, 65162-0254-30 |
Product
Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
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-0613-2020. 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.