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Class III · Lower riskActive recall

Glycopyrrolate

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854
Brand nameGLYCOPYRROLATE
Generic nameGLYCOPYRROLATE
Active ingredient(s)GLYCOPYRROLATE
Distributed by / forNovadoz Pharmaceuticals LLC, Piscataway, NJ 08854
NDC72205-070-72
Show the full FDA record
Full product labelGlycopyrrolate 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
Recalling firmNOVADOZ PHARMACEUTICALS LLC
DistributionUS Nationwide.
QuantityN/A
Recall initiated2025-12-15
Report date2026-02-04
Recall completed
Recall numberD-0300-2026
ClassificationClass III
FDA statusOngoing
Origin on filePiscataway NJ United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.