FDA Drug recall D-0495-2019
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (…
- FDA Drug
- Class II
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class II recall of Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (… by Tris Pharma, citing superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0495-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-15 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Tris Pharma |
| Distribution | US |
Product
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4.
Reason
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Identifiers
| upc | 050428399613 |
|---|---|
| code_info | Lot#: 00717006A, Exp 02/19 |
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-0495-2019%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.