Drug FDA Class III Ongoing Failed specifications

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

NOVADOZ PHARMACEUTICALS LLC Published Feb 4, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact NOVADOZ PHARMACEUTICALS LLC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Failed Impurities/Degradation Specifications

Hazards

Failed Impurities/Degradation Specifications · primary

Affected products (1)

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

GLYCOPYRROLATE · N/A

NDC: 72205-070, 72205-070-72

Lot codes: CB2505159A, CB2505161A

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

Affected areas

Nationwide

Timeline

Initiated

Dec 15, 2025
Published

Feb 4, 2026

Recall number: D-0300-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.