The Recall Desk
SevereFDA (Drugs)·D-0335-2019·Announced 2018-12-26

Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

Tris Pharma is recalling specific lots of infants' ibuprofen oral suspension because they may contain a higher concentration of the active ingredient.

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 agency classification is FDA Class II, and the hazard involves a superpotent drug (higher concentration of active ingredient), which poses a significant risk of adverse health consequences, aligning with the 'Severe' criteria for significant injury risk.

Plain-English summary

Tris Pharma Inc. is recalling 164,304 bottles of infants' IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP. The product is a 50 mg per 1.25 mL, dye-free berry flavor suspension distributed by Wal-Mart Stores, Inc. The recall involves three specific lots: 00717009A (Exp 02/19), 00717015A (Exp 04/19), and 00717024A (Exp 08/19).

The recall was initiated because the recalled lots may have a higher concentration of ibuprofen than intended. This is classified as a superpotent drug issue. The product was distributed nationwide in the USA through a distributor in Pennsylvania.

Consumers should check their bottles for the NDC 49035-125-23, UPC 0 78742 02016 7, and the specific lot numbers and expiration dates listed above. If the product matches these details, consumers should stop using it and contact the manufacturer or their healthcare provider for instructions on disposal or replacement.

The recalled product

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.
Manufacturer
Tris Pharma Inc.
Category
Drug — Ibuprofen Oral Suspension
Hazard
Affected units
164,304

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 (6)

  • Lot #: 00717009A
  • Exp 02/19
  • 00717015A
  • Exp 04/19
  • 00717024A
  • Exp 08/19

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Related recalls

Same manufacturer · Tris Pharma Inc.

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Same hazard · superpotent drug

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