Novadoz Pharmaceuticals LLC Recalls Glycopyrrolate Oral Solution Due to Impurity Specifications

What Happened

Novadoz Pharmaceuticals LLC has initiated a voluntary recall of several lots of Glycopyrrolate Oral Solution. The recall was triggered after testing revealed that the affected lots failed to meet established specifications for impurities and degradation. This Class III recall was officially classified by the FDA on January 28, 2026.

Which Products Are Affected

The recall involves Glycopyrrolate Oral Solution, 1 mg/5 mL, packaged in 16 oz. (473 mL) bottles. The product is a prescription drug (Rx only) manufactured by MSN Pharmaceuticals Inc. and distributed by Novadoz Pharmaceuticals LLC.

Product Details:

• NDC Number: 72205-070-72
• Lot Numbers & Expiration:
  • Lot # CB2505159A (Exp: 04/2027)
  • Lot # CB2505160A (Exp: 04/2027)
  • Lot # CB2505161A (Exp: 05/2027)
• Distribution: The product was distributed nationwide throughout the United States.

What You Should Do

Consumers, pharmacists, and healthcare providers are advised to check their current inventory for the affected lot numbers listed above. The recalling firm, Novadoz Pharmaceuticals LLC, initiated the process via notification letters. For further information regarding returns or specific medical concerns, patients should contact their healthcare provider or the distributing firm located at 20 Duke Rd Ste A, Piscataway, NJ 08854.

Why This Matters

This recall is necessary to ensure that prescription medications maintain their chemical integrity and purity. Using medications that have exceeded impurity or degradation limits may impact the efficacy or safety of the treatment.

Source

Information provided by the U.S. Food and Drug Administration (FDA) under recall number D-0300-2026.