The Recall Desk
SevereFDA (Drugs)·D-0336-2019·Announced 2018-12-26

Tris Pharma Recalls Superpotent Infants' Ibuprofen Suspension

Tris Pharma is recalling 19,488 bottles of Infants' Ibuprofen due to potential higher-than-labeled ibuprofen concentrations.

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, and the hazard involves a superpotent drug (higher concentration than labeled) for infants, which aligns with the rubric for Severe severity involving significant injury risk or Class II classification with potential for serious harm.

Plain-English summary

Tris Pharma Inc. is recalling 19,488 bottles of Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP. The product is a 50 mg per 1.25 mL, dye-free, non-staining berry flavor suspension in 0.5 FL OZ (15 mL) bottles. The specific lot affected is 00717024A with an expiration date of 08/19. The product was distributed by Family Dollar Services, Inc.

The recall was initiated because the recalled lots may contain a higher concentration of ibuprofen than labeled, classifying the product as a superpotent drug. This deviation from the standard concentration poses a risk of overdose for infants.

The product was distributed nationwide in the USA through one distributor in Pennsylvania. Consumers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, consumers should stop using it and contact their healthcare provider or the recalling firm 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 Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.
Manufacturer
Tris Pharma Inc.
Category
Drug — Pediatric OTC
Hazard
Affected units
19,488

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 #: 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.

See all →

Same hazard · superpotent drug

See all →