Data Foundry

Drug recalls 2022

Coated Back Relief Tablet — Class II drug recall D-0553-2022

Terminated recall by ULTRAtab Laboratories, Inc., reported 2022-02-16. CGMP Deviations

Recall numberD-0553-2022
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmULTRAtab Laboratories, Inc., Highland, NY, United States
Recall initiated2022-01-26
Classified2022-02-09
Reported by FDA2022-02-16
Terminated2025-01-07
Quantity25,769,495 tablets
Reason classescgmp
NDC62959-0800-00
Lot numbers18K005, 18K075, 18K098, 18M064, 19C021, 19C050, 19G081, 19G082, 19H012, 19H013, 19J036, 19J037

Product

Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00

Reason for recall

CGMP Deviations

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-0553-2022. 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.