Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only… — Class II drug recall D-0310-2020
Terminated recall by Novitium Pharma LLC, reported 2019-11-20, distributed nationwide. CGMP Deviations: Presence of NDMA impurity detected in product.
| Recall number | D-0310-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novitium Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2019-10-25 |
| Classified | 2019-11-10 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2021-03-17 |
| Distributed | Nationwide (US) |
| Quantity | 19,560 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 70954-0001-20 |
Product
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20
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-0310-2020. 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.