More Than 3,000 Bottles of Ibuprofen Have Been Recalled U.S. Nationwide

Especially around this time of year, we start to think more about what’s in our medicine cabinets in case cold, flu, or another ailment strikes. This week, the U.S. Food and Drug Administration is providing an advisory on recalled ibuprofen for what sound to be suspected product quality issues.

On October 29, 2024, a recall was initiated on 3,416 bottles of ibuprofen tablets, manufactured in India and distributed by Princeton, NJ-based Dr. Reddy’s Laboratories Inc. The details on the drug, which is prescription-only, are the following:

• 600 mg (milligram) tablets
• 500-count bottle
• National drug code (NDC): 55111-683-05
• Lot code: C5406201
• Expiration: 03/31/2028

On November 15, 2024, the FDA categorized this as a Class III recall. Class III is the FDA’s lowest risk level, which they define as “a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.” Their report on this recalled ibuprofen recall says the issue with the drug is “failed tablet/capsule specifications.” Sources suggest this may include, but is not limited to, defects to the tablets that developed out of the manufacturing or shipping processes.

At press time, the FDA called this recall “ongoing,” which means it’s possible patients who received the prescription for this drug may have it at home, and pharmacies, hospitals, or other clinical settings may also have the drug in stock. Their report said this ibuprofen was distributed “U.S. Nationwide.”

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