A pharmaceutical company recalled thousands of bottles of a commonly used allergy drug nationwide due to a failed test of the drug’s purity, according to a notice published by the Food and Drug Administration (FDA) this week.
According to the FDA’s recall website, 9,048 bottles of fexofenadine hydrochloride tablets in 180-milligram dosages are under recall.
The bottles have 150 tablets each, the notice added.
The reason for the recall is due to “Failed Impurities/Degradation Specifications,” which may mean that the drug failed to maintain its integrity across its shelf life.
The company recalling the drug is Sun Pharmaceutical Industries, India’s largest drug company and one of the biggest generic drugmakers in the world.
The drugs were distributed by New Jersey-based Ohm Laboratories, Inc., according to the notice.
Fexofenadine is commonly sold under the brand name Allegra, but the recall is impacting generic lots of the medication made by Sun Pharmaceutical.
The company recalled the medication on June 1, while the FDA issued its classification of the recall on June 30, the recall report said.
The notice was only published on the agency’s website this week.
The FDA classified it as a Class III recall, or its lowest risk level.
The agency defines it as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”
The impacted lots of recalled medication are lot DNG0283A with an expiration date of March 31, 2027; lot DNF0922A with an expiration of Oct. 31, 2026; and lot DNF0923B with an expiration of Oct. 31, 2026, the FDA notice said.
The Mayo Clinic says fexofenadine is “used to relieve the symptoms of hay fever” and hives on the skin.
Nearly 2 million estimated prescriptions of the drug were issued in 2023 in the United States, according to drug database site ClinCalc.
In September 2023, Sun Pharmaceutical said in a filing that ongoing problems at one of its factories in Gujarat, India, forced the FDA to place the facility on import alert, notifying agency personnel of products that might violate the FDA’s regulations.
In June 2024, the FDA said it inspected a separate Sun facility in India before it placed that facility on import alert.
According to the FDA letter, the company allegedly “failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product.”