Maximum Strength Acid Reducer — Class II drug recall D-1019-2020

Terminated recall by Perrigo Company PLC, reported 2020-03-25, distributed nationwide. CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Recall number	`D-1019-2020`
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	`00363-0950-02`, `11822-0950-00`, `21130-0568-62`, `30142-0891-02`, `36800-0950-62`, `37012-0950-62`, `37808-0710-02`, `41163-0950-62`, `41250-0950-02`, `41520-0609-62`, `46122-0041-62`, `55319-0523-62`, `55910-0423-62`, `59779-0950-62`, `70000-0378-01`
Lot numbers	`8BE1465`, `8CE1616`, `8DE1277`, `8DE1580`, `8DE1766`, `8FE1348`, `8FV1462`, `8GE1527`, `8GE1733`, `8GE1735`, `8GV1289`, `8HE1466`, `8HE1590`, `8JE2232`, `8KE2676`, `8LE2283`, `8LE2284`, `8LE2345`, `8ME2640`, `9AE2663`, `9AE2863`, `9AE2864`, `9BE3158`, `9CE3773`, `9CE3774`, `9CE3879`, `9EE2499`, `9EE2635`, `9EE2904`, `9FE2821`, `9FE2953`, `9FE3369`, `9GE2653`, `9GE2905`, `9GE3077`, `9GE3115`, `9HE3546`, `9HE3559`, `9JE2593`

Product

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pharmacy: 46122-041-62; NDC HEB: 37808-710-02; NDC Kroger: 30142-891-02; NDC Leader: 70000-0378-1; NDC Meijer: 41250-950-02; NDC Rite Aid: 11822-0950-0; NDC Shopko: 37012-950-62; NDC Signature Care: 21130-568-62; NDC Topcare: 36800-950-62; NDC Walgreens: 0363-0950-02

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-1019-2020. 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.