FDA Drug recall D-0642-2020
Glenmark Ranitidine Tablets USP 300 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 300 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-0642-2020 |
| 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 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Identifiers
| code_info | 7701030A 7701031A 7701062A 7701063A 7701110A 7701111A 7701112A 7701185A 7701186A 7701187A 7701188A 7701189A…7701030A 7701031A 7701062A 7701063A 7701110A 7701111A 7701112A 7701185A 7701186A 7701187A 7701188A 7701189A 7701269A 7701270A 7701278A 7701279A 7701386A 7701400A 7701401A 7701406A 7701421A 7701434A 7701435A 7701436A 7701452A 7701453A 7701521A 7701522B 7701553A 7701554A 7701555A 7701556A 7701582A 7701817A 7701828A 7701829A 7702001A 7702002A 7702003A 7702012A 7702026A 7702027A 7702064A 7702140A 7702253A 7702254A 7702285A 7702286A 7702287A 7702288A 7702294A 7702413A 7702462A 7702491A 7702492A 7702504A 7702505A 7702515A 7702698A 7702699A 7702700A 7702714A 7702719A 7702720A 7702747A 7702748A 7702749A 7702750A 7702751A 7702872A 7702873A 7702874A 7702917A 7702918A 7702919A 7702921A 7702922A 7702923A 7702945A 7703205A 7703410A 7703411A 7703412A 7703413A 7703414A 7703415A 7703451A 7703452A 7703453A 7703578A 7703579A 7703580A 7703581A 7703591A 7703592A 7703593A 7704372A 7704373A 7704374A 7704426A |
|---|
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-0642-2020%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.