Ranitidine 150 mg tablets — Class II drug recall D-0645-2020
Terminated recall by AAA Pharmaceutical, Inc., reported 2020-01-15. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
| Recall number | D-0645-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AAA Pharmaceutical, Inc., Lumberton, NJ, United States |
| Recall initiated | 2019-12-26 |
| Classified | 2020-01-06 |
| Reported by FDA | 2020-01-15 |
| Terminated | 2021-03-10 |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 37808-0196-01 |
Product
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
Reason for recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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-0645-2020. 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.