FDA Drug recall D-0565-2023
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
- FDA Drug
- Class II
- ongoing
- Published 2023-05-10
On 2023-05-10 the FDA classified a Class II recall of Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles by Family Dollar Stores, citing CGMP deviation: product outside labeled storage temperature requirements.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0565-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-31 |
| Published | 2023-05-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Family Dollar Stores |
| Distribution | US |
Product
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
Reason
CGMP deviation: product outside labeled storage temperature requirements.
Identifiers
| code_info | SKUs 0902867 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-0565-2023%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.