Ranitidine Tablets — Class II drug recall D-1003-2020
Terminated recall by American Health Packaging, reported 2020-03-18, distributed nationwide. CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
| Recall number | D-1003-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2019-11-20 |
| Classified | 2020-03-12 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2022-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 53,619 cartons |
| Reason classes | chemical contamination, cgmp |
| NDC | 60687-0322-01, 60687-0322-11 |
| Lot numbers | 179516, 179745, 180712, 180819, 181403, 182544, 183155, 183236, 185739, 186600, 186702 |
| Expiration dates | 2019-12-31, 2020-02-29, 2020-04-30, 2020-05-31, 2020-12-31 |
Product
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
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-1003-2020. 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.