The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0033-2025·Announced 2024-11-13

OTC Cold and Cough Medication Recalled Due to Crystallization

Denison Pharmaceuticals recalls Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo Pack due to crystallization and texture changes in affected bottles.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: FDA Class III recall for a quality defect (crystallization and lack of uniformity in product texture) rather than a direct health hazard. Class III recalls are the lowest classification and typically receive Low severity.

Plain-English summary

Denison Pharmaceuticals, LLC, through distributor Genexa Inc., is recalling Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo Pack. The recall involves 72,648 bottles distributed to two accounts that may have further distributed the product to retail locations. The product contains Dextromethorphan HBr, Guaifenesin, Acetaminophen, and Doxylamine Succinate (UPC 850015736155).

The recall was initiated due to crystallization and lack of uniformity in the product. Affected bottles contain chunky, grainy, and small crystal substances that represent a change in texture from the expected product consistency.

Affected lot numbers are 0104V (expiration 07/2025) and 0106V (expiration 09/2024). This is a Class III recall, the lowest classification for drug recalls.

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 — Over-the-Counter Cold and Cough Medicine
Hazard
Affected units
72,648

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# 0104V
  • Exp 07/2025
  • 0106V
  • Exp 09/2024

UPCs (1)

  • 850015736155

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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