HIGH

Novadoz Pharmaceuticals Recalls Glycopyrrolate Oral Solution Over Safety Concerns

Novadoz Pharmaceuticals LLC recalled Glycopyrrolate Oral Solution on December 15, 2025, due to failed impurities and degradation specifications. The recall affects Rx only products manufactured by MSN Pharmaceuticals Inc. Consumers should stop using this medication immediately.

Quick Facts at a Glance

Recall Date
December 15, 2025
Hazard Level
HIGH
Brands
GLYCOPYRROLATE, Novadoz Pharmaceuticals LLC
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Failed Impurities/Degradation Specifications

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact NOVADOZ PHARMACEUTICALS LLC or your healthcare provider for guidance. Notification method: Letter

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Product Details

The recalled Glycopyrrolate Oral Solution has the NDC 72205-070-72. It comes in a 16 oz. (473 mL) bottle. Specific lot numbers include CB2505159A, CB2505160A, and CB2505161A, with expiration dates of April 2027 and May 2027.

The Hazard

The product failed impurities and degradation specifications, which could compromise its safety and efficacy. This poses a considerable risk to consumers, especially those relying on this medication for health management.

Reported Incidents

There are currently no reported injuries or incidents associated with this recall. However, the potential for health risks remains high due to the nature of the impurities.

What to Do

Stop using the Glycopyrrolate Oral Solution immediately. Contact Novadoz Pharmaceuticals LLC or your healthcare provider for further guidance.

Contact Information

For more information, call Novadoz Pharmaceuticals LLC or visit their website. Details can also be found on the FDA's recall page.

Key Facts

  • Recall date: December 15, 2025
  • Report date: February 4, 2026
  • NDC: 72205-070-72
  • Dosage form: Oral solution
  • Risk level: High

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot # CB2505159A
CB2505160A
Exp Date: 04/2027
Lot # CB2505161A
Exp Date: 05/2027
UPC Codes
72205-070
72205-070-72
Affected States
ALL
Report Date
February 4, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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