OTC Allergy Med Recalled

Sun Pharmaceutical Industries Inc is recalling nearly 23,000 blister packs of Loratadine-D (loratadine and pseudoephedrine sulfate) extended-release tablets, 10 mg/240 mg, distributed by Major Pharmaceuticals. According to the November 3, 2021, US Food and Drug Administration (FDA) Enforcement Report, the product failed to meet standards for moisture limits.

The recall affects Loratadine-D extended-release tablets in 10-count blister packs (NDC 0904-5833-15) from lot AC14635 (Exp. 12/22). The tablets were distributed throughout the United States.

Sun Pharmaceutical Industries voluntarily initiated the recall October 12, 2021. The FDA designated the recall Class III on October 26, 2021. The classification signals that use of the recalled tablets is not likely to cause harm.

Loratadine-D is an over-the-counter antihistamine used to relieve seasonal allergy symptoms.