Nizatidine Oral Solution — Class II drug recall D-1253-2020
Terminated recall by Amneal Pharmaceuticals of New York, LLC, reported 2020-05-06, distributed nationwide. CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
| Recall number | D-1253-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY, United States |
| Recall initiated | 2020-04-15 |
| Classified | 2020-04-24 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2021-09-08 |
| Distributed | Nationwide (US) |
| Quantity | 11,258 bottles |
| Reason classes | chemical contamination, cgmp |
| NDC | 60846-0301, 60846-0301-15 |
Product
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
Reason for recall
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
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-1253-2020. 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.