Regular Strength Acid Reducer — Class II drug recall D-1012-2020
Terminated recall by Perrigo Company PLC, reported 2020-03-25, distributed nationwide. CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
| Recall number | D-1012-2020 |
|---|---|
| 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 | 00113-0876-65, 00363-1876-65, 00904-6715-46, 11673-0876-65, 21130-0118-65, 37808-0876-65, 41163-0931-65, 49348-0136-44, 55319-0876-65, 62011-0283-01, 69256-0876-65, 69842-0293-65 |
| Lot numbers | 8DE1363, 8EE1558, 8FE1450, 8GE1331, 8HE1221, 8JE1916, 8KE2243, 8KE2825, 8ME2685, 9AE2785, 9AE2786, 9CE3317, 9DE2721, 9EE2579, 9FE2957, 9GE2785, 9GE3218, 9HE3577 |
Product
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; NDC Health Mart: 62011-0283-1; NDC Leader: 62011-0283-1; NDC Major: 0904-6715-46; NDC Signature Care: 21130-118-65; NDC Sunmark: 49348-136-44; NDC Up & Up: 11673-876-65; NDC Walgreens: 0363-1876-65
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-1012-2020. 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.