FDA Drug recall D-0640-2020
Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 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 150 mg Rx Only 100 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-0640-2020 |
| 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 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01
Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Identifiers
| code_info | 7701033A 7701826A 7702344A 7702345A 7702489A 7702706A 7702707A 7702708A 7702858A 7702859A 7702860A 7702928A…7701033A 7701826A 7702344A 7702345A 7702489A 7702706A 7702707A 7702708A 7702858A 7702859A 7702860A 7702928A 7702929A 7703196A 7703634A 7704492A 7704493A 7705159A 19190289 19190342 19190372 |
|---|
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-0640-2020%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.