FDA Drug recall D-0597-2022
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentone…
- FDA Drug
- Class II
- terminated
- Published 2022-03-02
On 2022-03-02 the FDA classified a Class II recall of Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentone… by Perrigo, citing CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0597-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-26 |
| Published | 2022-03-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Perrigo |
| Distribution | US |
Product
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16
Reason
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Identifiers
| ndc | 49035-766-16 |
|---|---|
| code_info | Batch: 1CK1274, Exp 02/28/2023 |
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-0597-2022%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.