RecallRadar

FDA Drug recall D-0391-2022

Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufacture…

On 2022-01-26 the FDA classified a Class II recall of Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufacture… by Medique Products, citing CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0391-2022
ClassificationClass II
Statusterminated
Initiated2021-12-06
Published2022-01-26
Last updated2026-09-13 11:52 UTC
CompanyMedique Products
DistributionUS

Product

Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404

Reason

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

Identifiers

code_info
Lots: 6492 Exp. 06/2022; 6701 Exp. 10/2022; 6750 Exp. 12/2022; 6853 Exp. 01/2023; 6854 Exp. 01/2023; 6869 Exp. 02/2023;…Lots: 6492 Exp. 06/2022; 6701 Exp. 10/2022; 6750 Exp. 12/2022; 6853 Exp. 01/2023; 6854 Exp. 01/2023; 6869 Exp. 02/2023; 6898 Exp. 02/2023; 6901 Exp. 02/2023; 7059 Exp. 05/2023; 7060 Exp. 05/2023; 7064 Exp. 06/2023; 7065 Exp. 06/2023

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-0391-2022%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.