CVS, Walmart expand recall of infants' ibuprofen

EDITOR'S NOTE:This recall was expanded in January 2019, not in December 2019 as suggested. All of the product lots mentioned in this article have expired. This article has been corrected to reflect that information.

A pharmaceutical company that distributes liquid ibuprofen to CVS and Walmart is expanding a recall of its infant ibuprofen products.

According to a statement from the United States Food and Drug Administration, some CVS Health and Equate brand liquid infants' ibuprofen products may contain a higher concentration of ibuprofen than the label suggests. In the statement, the FDA says some packages have an ibuprofen concentration 10 percent above the specified limit.
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All of the bottles were labeled as a "Concentrated Ibuprofen Oral Suspension, USP" with a concentration of 50 mg of ibuprofen per 1.25 mL. The products were packaged in 0.5 oz and 1 oz bottles.

The FDA says some infants may be susceptible to the effects of ibuprofen, including kidney damage. However, most children can tolerate doses of ibuprofen up to 700 percent of the recommended amount.

A previous recall, issued in 2018, included 0.5 oz bottles sold under the Family Wellness brand at Family Dollar. At the time, all stores were told to stop selling the affected products.



No serious injuries have been reported in connection to this recall.

The expanded recall includes the following products:
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• CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle, expiration date 12/19, sold at CVS Pharmacy
• Equate: Infants' Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle, expiration date 2/19, sold at WalMart
• CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle, expiration date 2/19, sold at CVS Pharmacy

The 2018 recall includes the following products:

• Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle, expiration date 2/19, sold at WalMart
• Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle, expiration date 4/19, sold at WalMart
• Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle, expiration date 8/19, sold at WalMart
• CVS Health: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle, expiration date 8/19, sold at CVS
• Family Wellness: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle, expiration date 8/19, sold at Family Dollar

For more information about this recall, click here.