FDA Drugs recall ·

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

Recall number
D-0300-2026
Date
(initiated December 15, 2025)
Company / brand
Novadoz Pharmaceuticals LLC
20 Duke Rd Ste A, Piscataway, NJ, United States
Category
Drugs › Class III
Classification
Class III
Status
Ongoing
Units affected
N/A
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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

Why was it recalled?

Failed Impurities/Degradation Specifications

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Distribution

US Nationwide.

What does Class III mean?

Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).

Source: FDA (drugs), recall D-0300-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.