Maximum Strength Acid Reducer — Class II drug recall D-1028-2020
Terminated recall by Perrigo Company PLC, reported 2020-03-25, distributed nationwide. CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
| Recall number | D-1028-2020 |
|---|---|
| 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 | 00113-7852-82, 00363-0852-82, 21130-0116-82, 37808-0507-82, 59779-0540-82 |
| Lot numbers | 8AE1291, 8AE1785, 8BE1415, 8CE1525, 8DE1201, 8DE1741, 8EE1323, 8FE1806, 8GE1965, 8HE1517, 8JE2161, 8KE2565, 8LE2261, 8ME2548, 9AE2658, 9BE3018, 9CE3861, 9DE3244, 9FE2820, 9FE3373, 9GE3094, 9HE3449, 9JE2665 |
Product
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82
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-1028-2020. 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.