infants* IBUPROFEN — Class II drug recall D-0335-2019
Terminated recall by Tris Pharma Inc., reported 2018-12-26, distributed nationwide. Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
| Recall number | D-0335-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tris Pharma Inc., Monmouth Junction, NJ, United States |
| Recall initiated | 2018-11-26 |
| Classified | 2018-12-17 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2021-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 164,304 bottles |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00078742020167 |
| NDC | 49035-0125-23 |
| Lot numbers | 00717009A, 00717015A, 00717024A, 02/19, 04/19, 08/19 |
Product
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
Reason for recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
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-0335-2019. 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.