Maximum Strength Acid Reducer — Class II drug recall D-1027-2020
Terminated recall by Perrigo Company PLC, reported 2020-03-25, distributed nationwide. CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
| Recall number | D-1027-2020 |
|---|---|
| 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 | 00113-7950-01, 59779-0950-01 |
| Lot numbers | 8BE1032, 8BE1486, 8CE1638, 8DE1361, 8DE1612, 8FE1354, 8GE1737, 8HE1654, 8JE2237, 8KE2726, 8LE2369, 8ME2645, 9AE2777, 9CE3315, 9DE2720, 9EE2578, 9FE2956, 9GE2698, 9GE3202 |
Product
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01
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-1027-2020. 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.