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.
What this means for you
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
- 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
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