A nationwide recall has been issued for 89,592 bottles of children's ibuprofen after reports of a foreign substance in the medication, the U.S. Food and Drug Administration (FDA) says.
Strides Pharma, the medication's manufacturer, issued the recall after it "received complaints for a gel-like mass and black particles in the product," according to the FDA enforcement report.
The medication was made in India and manufactured for Taro Pharmaceuticals U.S.A., Inc., and sold across the United States.
What to Expect reached out to Strides Pharma and Taro Pharmaceuticals representatives for comment. We will update this story if we receive a response.
Which bottles of children's ibuprofen are recalled?
The recall is for liquid children's ibuprofen that comes in bottles of 4 fluid ounces (120 milliliters). You may have a recalled bottle if the label says the following:
- It has a lot number of 7261973A or 7261974A.
- It has an expiration date of Jan. 31, 2027.
- It was manufactured for Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532.
- It was made in India.
What should you do if you have a recalled bottle?
To be on the safe side, avoid giving your child the recalled medication unless necessary. If you think you gave your child some of the recalled medication, call your health care provider.
The FDA issued a Class II recall for the ibuprofen, which means using it "may cause temporary health consequences, but the probability of a serious health issue is remote." The FDA says it's generally safe to continue using a medication under a Class II recall, but check with your provider first.
And always check with your pediatrician before giving any medications to a child under 2 years old.
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