FDA Drug recall D-0641-2020
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd
- FDA Drug
- Class II
- ongoing
- Published 2020-01-15
On 2020-01-15 the FDA classified a Class II recall of Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd by Glenmark Pharmaceuticals Usa, citing CGMP Deviations: Presence of NDMA impurity detected in product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0641-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-12-17 |
| Published | 2020-01-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | n/a |
Product
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30
Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Identifiers
| code_info | 7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490 |
|---|
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-0641-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.