The Recall Desk
SevereFDA (Drugs)·D-0494-2019·Announced 2019-02-20

Tris Pharma Recalls Superpotent Infant Ibuprofen Suspension

Tris Pharma is recalling specific lots of infant ibuprofen suspension because the medication may contain higher concentrations than labeled.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) under the rubric, particularly given the risk of overdose from superpotent medication.

Plain-English summary

Tris Pharma Inc. is recalling 35,328 bottles of infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle. The product is distributed by Wal-Mart Stores, Inc. and carries NDC 49035-125-24.

The recall is being conducted because the recalled lots are classified as superpotent, meaning they may have a higher concentration of ibuprofen than the amount stated on the label. The affected lot number is 00717005A with an expiration date of 02/19.

The product was distributed nationwide in the USA through one distributor. Consumers should check their inventory for this specific lot number and expiration date. If found, they should stop using the product and contact their healthcare provider or the recalling firm for instructions.

The recalled product

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.
Manufacturer
Tris Pharma Inc.
Category
Drug — NSAID
Hazard
Affected units
35,328

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot#: 00717005A
  • Exp 02/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Tris Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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Same manufacturer · Tris Pharma Inc.

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Same hazard · superpotent drug

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