Regular Strength Acid Reducer — Class II drug recall D-1013-2020
Terminated recall by Perrigo Company PLC, reported 2020-03-25, distributed nationwide. CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
| Recall number | D-1013-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perrigo Company PLC, Allegan, MI, United States |
| Recall initiated | 2019-10-23 |
| Classified | 2020-03-13 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2020-11-06 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 00904-6715-52, 41250-0252-72, 49348-0136-12, 62011-0283-02 |
| Lot numbers | 8DE1367, 8EE1559, 8FE1451, 8GE1340, 8HE1222, 8JE1917, 8KE2245, 8KE2831, 8ME2724, 9AE2831, 9CE3339, 9DE2747, 9EE2636, 9FE2971, 9GE2793, 9GE3220 |
Product
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;
Reason for recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
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-1013-2020. 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.