Parents Beware: Infant Ibuprofen Recalled Over Dosage Problem

infant ibuprofen recall
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Ibuprofen is one of the most common over-the-counter medications given to young kids, but a huge new recall on the drug has parents on high alert. Tris Pharma has issued a recall on several batches of infant ibuprofen sold at CVS, Family Dollar, and Walmart after discovering that the medications may contain concentrations of ibuprofen that are too high and put babies at risk.

  • The recalls is for three lots of Concentrated Oral Suspension Ibuprofen, USP (NSAID) 50 mg per 1.25 mL.

    The medication is intended for infants between the ages of 6 months and 23 months old. So far, there are no reports of injury, but Tris Pharma warns in a press release that the recalled medications contain too much ibuprofen per dose and have a "remote chance" of causing adverse effects, so they're recalling it out of an abundance of caution.

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  • Adverse effects from ibuprofen overdose include nausea, vomiting, epigastric pain, and diarrhea.

    In severe cases, tinnitus (ringing of the ears), headache, and gastrointestinal bleeding are also possible adverse effects.

  • The affected products include:

    Equate: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle

    • Sold at Wal-Mart
    • NDC: 49035-125-23
    • Lots: 00717009A, 00717015A, 00717024A
    • Expiration dates: 02/19, 04/19, 08/19

    CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle

    • Sold at CVS Pharmacy
    • NDC: 59779-925-23
    • Lot: 00717024A
    • Expiration date: 08/19

    Family Wellness: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle

    • Sold at Family Dollar
    • NDC: 55319-250-23
    • Lot: 00717024A
    • Expiration date: 08/19
  • Retailers and wholesalers are being warned to halt sales of the affected products immediately.

    If you have an affected product, you should throw it away or seek a refund. Consumers are being asked to direct any questions about the recall to Tris customer service at 732-940-0358 (Monday through Friday, 8 a.m. ET to 5 p.m. PT).

    To report adverse effects, you can submit an online form to the Food and Drug Administration (FDA), download the form and fax it to 800-FDA-0178, or call 800-332-1088 to request a reporting form by mail.