FDA Recall D-0034-2025

Denison Pharmaceuticals, LLC · Lincoln, RI

Class III Ongoing 596 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018

Lot / code: Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025

Quantity: 105,048 bottles

Reason for recall

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

Recall record

Recall number: D-0034-2025
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Recall initiated: 2024-09-25
Classified by FDA Center: 2024-11-01
FDA published: 2024-11-13
Recalling firm: Denison Pharmaceuticals, LLC
Firm location: Lincoln, RI

Drug identification

Brand name(s): MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK
Generic name(s): DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE
Manufacturer(s): Genexa Inc.
NDC(s): 69676-0079

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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