Recall alert: Infant ibuprofen sold at Walmart, CVS, Family Dollar

Tris Pharma, Inc., has recalled three lots of infant ibuprofen because of a formulation error creating a potency that could cause babies to develop permanent kidney injuries.

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Equate, CVS Health and Family Wellness brands involved in recall

The Monmouth Junction, NJ-based company issued the voluntary recall on December 5 because the recalled products may have have higher concentrations of ibuprofen than stated on the packaging.

The company says babies who ingest the recalled product may experience nausea, vomiting, epigastric pain, diarrhea, tinnitus, headaches and gastrointestinal bleeding.

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There is also “a remote possibility” that susceptible infants could become vulnerable to permanent NSAID-associated renal injury.

Better to play it safe than sorry on this one, parents! The labels of the affected products look this:

family wellness infant ibuprofen
(PRNewsfoto/Tris Pharma, Inc.)
cvs health infant ibuprofen
(PRNewsfoto/Tris Pharma, Inc.)
equate infant ibuprofen
(PRNewsfoto/Tris Pharma, Inc.)

Meanwhile, here the lot numbers, expiration dates and NDC numbers on the affected products:

Retailer Product Lot numbers and expiration dates NDC
Walmart Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
  • 00717009A (expiration 02/19)
  • 00717015A (expiration 04/19)
  • 00717024A (expiration 08/19)
49035-125-23
CVS CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
  • 00717024A (expiration 08/19)
59779-925-23
Family Dollar Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
  • 00717024A (expiration 08/19)
55319-250-23

If you have any of these in your medicine cabinet at home, please throw it out immediately or return it to the store for a refund.

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