RecallRadar

FDA Drug recall D-0533-2022

Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00

On 2022-02-16 the FDA classified a Class II recall of Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00 by Ultratab Laboratories, citing CGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0533-2022
ClassificationClass II
Statusterminated
Initiated2022-01-26
Published2022-02-16
Last updated2026-09-13 11:52 UTC
CompanyUltratab Laboratories
Distributionn/a

Product

Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00

Reason

CGMP Deviations

Identifiers

code_infoProduct Codes: L203L Bulk Lots: 18K012, 19E091

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0533-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.