Ranitidine Tablets — Class II drug recall D-0795-2020
Terminated recall by Denton Pharma, Inc., reported 2020-01-29, distributed nationwide. CGMP Deviations: Presence of NDMA impurity detected in product.
| Recall number | D-0795-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Denton Pharma, Inc., North Blenheim, NY, United States |
| Recall initiated | 2019-12-20 |
| Classified | 2020-01-20 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2023-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 467 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 70934-0287-15, 70934-0287-90 |
| Expiration dates | 2021-10-31, 2021-11-30, 2022-02-28, 2022-05-31 |
Product
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
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-0795-2020. 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.