Allergy Meds Distributed by Multiple Outlets Recalled

Dr Reddy’s Laboratories Inc is voluntarily recalling extended-release fexofenadine-pseudoephedrine tablets distributed by various outlets throughout the United States for failing to meet dissolution specifications. The recalls were included in the January 26, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were made in India:

• Dr Reddy’s fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg extended-release tablets in 10-tablet boxes (UPC 343598823355) from lot AC2103328D (Exp. 1/31/23), 20-tablet boxes (UPC 343598823140) from lot AC2000968C (Exp. 8/31/22), and 30-tablet boxes (UPC 343598823317) from lots AC2103330C (Exp. 1/31/23) and AC2106452D (Exp. 3/31/23), distributed by Dr Reddy’s Laboratories, Princeton, NJ;
• CVS Health Allergy Relief D (fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg) extended-release tablets in 20-tablet boxes (UPC 050428436189) from lots AC2000968A and AC2000968F (Exp. 8/31/22), and 30-count  boxes (UPC 050428290538) from lots 79C002624B (Exp. 4/30/22) and AC2103330G and AC2103330H (Exp. 1/31/23), distributed by CVS Pharmacy Inc, Woonsocket, RI;
• Equate Allergy Relief D (fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg) extended-release tablets in 20-tablet boxes (NDC 49035-273-20) from lots 79C002624A (Exp. 4/30/22), AC2000968B (Exp. 8/31/22), AC2103328F (Exp. 1/31/23), AC2103330E (Exp. 1/31/23), and AC2106452I (Exp. 3/31/2023), and 30-tablet boxes (NDC 49035-273-30) from lots 79C002625A (Exp. 4/30/22), AC2103328E (Exp. 1/31/23), AC2103330F (Exp. 1/31/23), and AC2106452G (Exp. 3/31/23), distributed by Walmart Inc, Bentonville, AR;
• Kroger Allergy Relief-D (fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg) extended-release tablets in 20-tablet boxes (NDC 30142-611-14) from lots AC2000968E (Exp. 8/31/22), AC2103328A and AC2103330I (Exp. 1/31/23), and AC2106452B (Exp. 3/31/23), distributed by the Kroger Co, Cincinnati, OH;
• Leader 12-Hour Allergy & Congestion Relief (fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg) extended-release tablets in 20-tablet boxes (NDC 70000-0518-1) from lots 79C002625B (Exp. 4/30/22), AC2103328G (Exp. 1/31/23), and AC2106452C (Exp. 3/31/23), distributed by Cardinal Health, Dublin, OH;
• Quality Choice Allergy & Congestion (fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg) extended-release tablets in 10-tablets boxes (NDC 63868-729-10) from lots 79C002624D and 79C002625C (Exp. 4/30/22), distributed by CDMA Inc, Novi, MI;
• Rite Aid Pharmacy Allergy & Congestion (fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg) extended-release tablets in 20-tablet boxes (UPC 011822738873) from lots AC2103330D (Exp. 1/31/23) and AC2106452E (Exp. 3/31/23), distributed by Rite Aid, Camp Hill, PA;
• Rugby Antihistamine and Nasal Decongestant (fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg) extended-release tablets in 30-tablet boxes (NDC 0536-1242-07) from lot AC2106452F (Exp. 3/31/23), distributed by Rugby Laboratories, Livonia, MI; and
• Wal-Fex D fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg extended-release tablets in 20-tablet boxes (NDC 0363-1606-20) from lots AC2000968D (Exp. 8/31/22), AC2103330J (Exp. 1/31/23), AC2106452A and AC2106452H (Exp. 3/31/23), and 30-tablets boxes (NDC 0363-1606-30) from lots 79C002624C (Exp. 4/30/22), and AC2103328B, AC2103328C, AC2103330A, and AC2103330B (Exp. 1/31/23), distributed by Walgreen Co, Deerfield, IL.

Dr Reddy’s Laboratories initiated the recalls January 4, 2022. On January 18, 2022, the FDA designated them Class III, suggesting use of the recalled 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.