OTC Antihistamine-Decongestant Tablets Recalled

Dr Reddy’s Laboratories Inc is recalling extended-release fexofenadine-pseudoephedrine tablets distributed by various outlets throughout the United States. According to the December 15, 2021, US Food and Drug Administration (FDA) Enforcement Report, the tablets are being recalled because samples failed to meet dissolution specifications.

The recall affects the following products:

• Allergy and Congestion (fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg), 20 extended-release tablets (NDC 11822-7388-5), from lot AC2103329E (Exp. 1/23), distributed by Rite Aid, Camp Hill, PA;
• fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg, 20 extended-release tablets (NDC 69842-249-20), from lot AC2103329I (Exp. 1/23), distributed by CVS Pharmacy Inc, Woonsocket, RI;
• fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg, 30 extended-release tablets (NDC 69842-249-30), from lot AC2103329C (Exp. 1/23), distributed by CVS Pharmacy Inc, Woonsocket, RI;
• fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg, 30 extended-release tablets (NDC 0638-1242-07), from lot AC2103329D (Exp. 1/23), distributed by Rugby Laboratories, Livonia, MI;
• fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg, 20 extended-release tablets (NDC 43598-823-14), from lot AC2103329F (Exp. 1/23), distributed by Dr Reddy's Laboratories Inc, Princeton, NJ;
• fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg, 30 extended-release tablets (NDC 43598-823-31), from lot AC2103329A, distributed by Dr Reddy's Laboratories Inc, Princeton, NJ.
• 12hr Allergy & Congestion Relief (fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg), 20 extended-release tablets (NDC 70000-0518-1), from lot AC2103329G (Exp. 1/23), distributed by Cardinal Health, Dublin, OH; and
• fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg, 30 extended-release tablets (NDC 49035-273-30), from lot AC2103329B, distributed by Walmart Inc, Bentonville, AR.

Dr Reddy’s Laboratories initiated the recalls November 12, 2021. On December 7, 2021, the FDA designated them Class III. Under the recall classification, use of the tablets is not likely to cause harm.

Fexofenadine hydrochloride-pseudoephedrine hydrochloride is an over-the-counter antihistamine and nasal decongestant used to relieve allergy symptoms.