# FDA recall D-0494-2019

> **Tris Pharma Inc.** · Class II · drug recall initiated 2019-01-15.

## Product

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.

## Reason for recall

Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.

## Distribution

One distributor who further distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-0494-2019
- **Recalling firm:** Tris Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-15
- **Report date:** 2019-02-20
- **Termination date:** 2023-03-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Monmouth Junction, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0494-2019

## Citation

> AI Analytics. FDA recall D-0494-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0494-2019. Source: US FDA. Licensed CC0.

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