Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets… — Class II drug recall D-0639-2020
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2020-01-15. CGMP Deviations: Presence of NDMA impurity detected in product.
| Recall number | D-0639-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2019-12-17 |
| Classified | 2020-01-05 |
| Reported by FDA | 2020-01-15 |
| Quantity | 208,668 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 68462-0248-60 |
Product
Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
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-0639-2020. 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.