The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0034-2025·Announced 2024-11-13

OTC cough and congestion medication recalled for crystallization

Denison Pharmaceuticals is recalling its Maximum Strength Cough and Chest Congestion medication due to crystallization in bottles. The product, distributed by Genexa Inc., may contain chunks, graininess, or crystal substances that affect uniformity.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall for a product quality defect involving crystallization that affects uniformity. No safety hazards or illnesses are explicitly described in the source. Class III recalls are typically assigned lower severity scores (1 or 2).

Plain-English summary

Denison Pharmaceuticals, LLC is recalling Maximum Strength Cough and Chest Congestion medication distributed by Genexa Inc. The recalled product consists of Kids' Cough and Chest Congestion (containing Dextromethorphan HBr 5mg and Guaifenesin 100mg) packaged in 4 oz bottles. A total of 105,048 bottles are affected.

The recall is due to crystallization in the product, resulting in a lack of uniformity, texture changes, and the appearance of small crystal substances inside the bottles. Affected lots include Lot #0813V (expiration 06/2025) and Lot #0103V (expiration 03/2025), with UPC code 850015736018.

The recalled product was distributed to two accounts that may have distributed the product further to retail locations.

The recalled product

Product
MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK (DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE)
Brand
MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK
Manufacturer
Denison Pharmaceuticals, LLC
Category
Drug — OTC Cough and Cold
Hazard
Affected units
105,048

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot#: 0813V
  • Exp 06/2025
  • 0103V
  • Exp 03/2025

UPCs (1)

  • 850015736018

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Denison Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK

Same manufacturer · Denison Pharmaceuticals, LLC

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Same hazard · crystallization

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