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Class III: unlikely to cause harmOngoing

Novadoz Pharmaceuticals Glycopyrrolate Oral Solution Recall

Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz

NOVADOZ PHARMACEUTICALS LLC · Piscataway, NJ

Risk level
Class III
Reported by FDA
Feb 4, 2026
Recall ID
D-0300-2026
Check your lot numberHow we source this data

Summary

Novadoz Pharmaceuticals recalled Glycopyrrolate Oral Solution starting Dec 15, 2025. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0300-2026 on Feb 4, 2026. Reason: Failed Impurities/Degradation Specifications. Status: Ongoing.

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72

Lot numbers, UPCs & expiration codes

Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027

Where it was sold

US Nationwide.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0300-2026
Classification
Class III
Status
Ongoing
Recall initiated
Dec 15, 2025
FDA report date
Feb 4, 2026
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
NOVADOZ PHARMACEUTICALS LLC

Original FDA data

Every field from FDA enforcement report D-0300-2026, exactly as published.

Show all FDA fields
City
Piscataway
State
NJ
Status
Ongoing
Country
United States
Event ID
98156
Address
20 Duke Rd Ste A
Code information
Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027
Postal code
08854-3714
Report date
Feb 4, 2026
Product type
Drugs
Recall number
D-0300-2026
Classification
Class III
Recalling firm
NOVADOZ PHARMACEUTICALS LLC
Reason for recall
Failed Impurities/Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72
Distribution pattern
US Nationwide.
Recall initiation date
Dec 15, 2025
Initial firm notification
Letter
Center classification date
Jan 28, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0300-2026, published Feb 4, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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