Maximum Strength Acid Reducer — Class II drug recall D-1023-2020
Terminated recall by Perrigo Company PLC, reported 2020-03-25, distributed nationwide. CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
| Recall number | D-1023-2020 |
|---|---|
| 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 | 00113-7950-09, 00363-0950-09, 11673-0950-09, 30142-0891-09, 36800-0950-09, 46122-0533-09, 49035-0800-09, 59779-0950-09 |
| Lot numbers | 8AE1884, 8BE1466, 8CE1617, 8DE1318, 8DE1319, 8DE1611, 8DE1767, 8EE1326, 8FE1350, 8FE1352, 8GE1736, 8GE1840, 8GE1859, 8HE1592, 8HE1593, 8HE1594, 8JE2233, 8JE2234, 8KE2704, 8LE2360, 8ME2641, 8ME2642, 9AE2675, 9AE2676, 9CE3263, 9CE3265, 9CE3881, 9DE2585, 9EE2501, 9EE2502, 9FE2825, 9FE2827, 9GE2657, 9GE3122, 9GE3124, 9HE3555 |
Product
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09
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-1023-2020. 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.