Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only… — Class II drug recall D-0127-2020
Terminated recall by Sandoz, Inc, reported 2019-10-16, distributed nationwide. CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
| Recall number | D-0127-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz, Inc, Princeton, NJ, United States |
| Recall initiated | 2019-09-23 |
| Classified | 2019-10-07 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2023-07-14 |
| Distributed | Nationwide (US) |
| Quantity | 100,314 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 00781-2855-60 |
Product
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
Reason for recall
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
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-0127-2020. 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.