The medication is for a certain demographic of patients—here's why you'll want to remove it from your home before it's needed.
By far, data, such as from Healthgrades, show ibuprofen is one of the most-trusted over-the-counter medications for fever reduction, pain relief, and more. If a licensed healthcare professional recommends ibuprofen for your child, it may be to address inflammation. Ibuprofen is a non-steroidal anti-inflammatory drug—often abbreviated to NSAID—that targets inflammation specifically, whereas in contrast, a medicine like Children’s Tylenol works to temporarily increase the body’s tolerance for pain.
Notably, the dosage for a children’s over-the-counter drug of this type will be substantially lower than the adult version. The delivery method will also differ, as many children can’t yet swallow pills.
This week, the Food and Drug Administration (FDA) published a report on a 100-milligram (mg) children’s liquid oral ibuprofen (referred to as “oral suspension” format). The FDA notice indicates the recall was called over “Presence of foreign substance,” namely, “the firm received complaints for a gel-like mass and black particles in the product.”
The firm is Strides Pharma, Inc., in Bridgewater, NJ, a company saying it “specializes in soft-gel capsules (SGC), oral solids, modified releases, topicals and liquids.” It appears they partner on this product with the Hawthorne, NY offices of Taro Pharmaceuticals, “owned by Sun Pharma, a global healthcare company with innovative therapies, generic medicines and consumer healthcare products.” The FDA report indicates the product was made in India. It’s possible, but not confirmed, that this was a store-brand or other generic product licensed under a budget label.
The notice states 89,592 bottles—”100 mg per 5mL, 4 FL OZ (120 mL)”—were recalled “U.S.A. Nationwide.” Lot numbers and expiration date are said to be 7261973A, 7261974A, Exp 01/31/2027, respectively. The National Drug Code (NDC) is listed as 51672-5321-8. The recall appears to have been first initiated on March 2.
From the report it’s unclear whether the documented “foreign substance” occurred from chemical degradation due to environmental exposure, contamination from microbes or broken packaging, or another issue altogether. The FDA has named this a Class II recall, which they deem “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
As the medication is a children’s product, it’s worth practicing utmost caution. While this notice doesn’t offer specific steps for remedy, it would be advisable to speak with a pediatrician or pharmacist for suggested next steps.
For more wellness updates, subscribe to The Healthy newsletter and follow The Healthy on Facebook and Instagram. Keep reading:
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