RecallRadar

FDA Drug recall D-0563-2023

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 coun…

On 2023-05-10 the FDA classified a Class II recall of Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 coun… by Family Dollar Stores, citing CGMP deviation: product outside labeled storage temperature requirements.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0563-2023
ClassificationClass II
Statusongoing
Initiated2023-03-31
Published2023-05-10
Last updated2026-09-13 11:52 UTC
CompanyFamily Dollar Stores
DistributionUS

Product

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.

Reason

CGMP deviation: product outside labeled storage temperature requirements.

Identifiers

code_infoSKUs a) 0901458; b) 0913023; c) 0999259 stored and distributed from DCs 07/28/2022 through 03/31/2023.

Status history

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

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0563-2023%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.