FDA·Medicines·February 4, 2026

Novadoz recalls Glycopyrrolate Oral Solution 1 mg/5 mL because it failed impurity and breakdown tests

Failed Impurities/Degradation Specifications.

What to do

The notice does not give instructions. Read the official notice for details.

Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.

Recall details

Product
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
Hazard
Failed Impurities/Degradation Specifications
Units
N/A
Where sold
US Nationwide.
FDA classification
Class III · Ongoing
Classified by FDA
January 28, 2026
Recall started
December 15, 2025
FDA enforcement report
February 4, 2026
Identifiers
  • Codes: Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027
  • FDA recall number: D-0300-2026

Details are taken from the official notice. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.

Official notice

The notice's own wording from FDA.

Product
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
Reason for recall
Failed Impurities/Degradation Specifications
Classification
Class III (Ongoing)
Distribution
US Nationwide.
Quantity
N/A

Related recalls