Infants' Ibuprofen — Class II drug recall D-0495-2019
Terminated recall by Tris Pharma Inc., reported 2019-02-20, distributed nationwide. Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
| Recall number | D-0495-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tris Pharma Inc., Monmouth Junction, NJ, United States |
| Recall initiated | 2019-01-15 |
| Classified | 2019-02-14 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2023-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 35,280 bottles |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00050428399613 |
| NDC | 50428-1252-04 |
| Lot numbers | 00717006A, 02/19 |
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 for recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0495-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.