RANITIDINE TABLETS — Class II drug recall D-0632-2020
Ongoing recall by Granules India Limited, reported 2020-01-08, distributed in NJ, NY, OR. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
| Recall number | D-0632-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Granules India Limited, Qutbullapur Mandal, Ranga Redd, N/A, India |
| Recall initiated | 2019-12-13 |
| Classified | 2019-12-29 |
| Reported by FDA | 2020-01-08 |
| Distributed | NJ, NY, OR |
| Quantity | 23,090,000 tablets |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 62207-0773, 62207-0773-32, 62207-0773-36, 62207-0773-41, 62207-0773-47, 62207-0773-58, 62207-0774, 62207-0774-36, 62207-0774-41, 62207-0774-47, 62207-0774-58 |
Product
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
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-0632-2020. 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.