Ranitidine Syrup — Class II drug recall D-0631-2020
Terminated recall by American Health Packaging, reported 2020-01-08, distributed nationwide. CGMP Deviations: Presence of NDMA impurity detected in product.
| Recall number | D-0631-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2019-11-01 |
| Classified | 2019-12-29 |
| Reported by FDA | 2020-01-08 |
| Terminated | 2022-08-03 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 60687-0260-23, 60687-0260-69 |
| Lot numbers | 01/31, 02/29, 03/31, 12/31, 177874, 178413, 183449, 183723, 184278, 184445, 186563, 187652, 187691, 2020, 2021 |
| Expiration dates | 2020-10-31, 2021-05-31 |
Product
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
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-0631-2020. 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.