Data Foundry

Drug recalls 2022

Pyrazinamide Tablets — Class II drug recall D-0568-2022

Terminated recall by ANI Pharmaceuticals, Inc., reported 2022-02-23, distributed nationwide. cGMP Deviations

Recall numberD-0568-2022
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmANI Pharmaceuticals, Inc., Baudette, MN, United States
Recall initiated2022-02-15
Classified2022-02-17
Reported by FDA2022-02-23
Terminated2022-10-25
DistributedNationwide (US)
Quantity5,477 bottles
Reason classescgmp
NDC67253-0660-10
Lot numbers19B064A
Expiration dates2022-03

Product

Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.

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-0568-2022. 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.