FDA Drug recall D-0632-2020
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
- FDA Drug
- Class II
- ongoing
- Published 2020-01-08
On 2020-01-08 the FDA classified a Class II recall of RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32 by Granules India, citing CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0632-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-12-13 |
| Published | 2020-01-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Granules India |
| Distribution | NJ, NY, OR |
Product
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Identifiers
| ndc | 62207-774-58 |
|---|---|
| ndc | 62207-774-41 |
| ndc | 62207-774-47 |
| ndc | 62207-774-36 |
| ndc | 62207-773-58 |
| ndc | 62207-773-41 |
| ndc | 62207-773-47 |
| ndc | 62207-773-32 |
| ndc | 62207-773-36 |
| code_info | 7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0632-2020%22
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