HIGHFDA DRUG

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.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
December 15, 2025
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
GLYCOPYRROLATE, Novadoz Pharmaceuticals LLC
Product type
Glycopyrrolate Oral Solution
Model numbers
Lot # CB2505159A, CB2505160A, Exp Date: 04/2027, Lot # CB2505161A, Exp Date: 05/2027
UPC codes
72205-070, 72205-070-72
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 15, 2025

  2. Reported by FDA DRUG

    February 4, 2026

  3. RecallRadar source check

    February 11, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

Glycopyrrolate Oral Solution is used to treat various medical conditions by reducing secretions. Patients typically use it for gastrointestinal issues or as part of anesthesia protocols.

Why This Is Dangerous

The product's failure to meet impurities and degradation specifications indicates potential contamination or instability, which can compromise its effectiveness and safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face health risks if they continue using this medication. The recall emphasizes the importance of monitoring pharmaceutical products for safety.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on the product label.
  2. Verify if your product matches the recalled lot numbers: CB2505159A, CB2505160A, CB2505161A.
  3. Look for the expiration dates: April 2027 and May 2027.

Where to find product info

Lot numbers and expiration dates can usually be found on the label or packaging of the product.

What timeline to expect

Expect a refund or guidance within 4-6 weeks after contacting the manufacturer.

If the manufacturer is unresponsive

  • Follow up with Novadoz Pharmaceuticals LLC via email or phone.
  • Contact the FDA to report unresponsiveness.

How to prevent similar issues

  • Always check for recalls on medications before purchase.
  • Consult with your healthcare provider about alternative medications.
  • Review product packaging for safety certifications.

Documentation advice

Keep a record of your purchase receipt, correspondence with the manufacturer, and any notes regarding your health status.

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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.

Key Facts

  • Recall date: December 15, 2025
  • Report date: February 4, 2026
  • Dosage form: Oral solution
  • Risk level: High

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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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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