December 2025 FDA Recall Glycopyrrolate by Novadoz Pharmaceuticals Llc
D-0300-2026 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Novadoz Pharmaceuticals Llc on December 15, 2025 for the product Glycopyrrolate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0300-2026
Failed Impurities/Degradation Specifications
12-15-2025
02-04-2026
N/A
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NOVADOZ PHARMACEUTICALS LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# CB2505159A, CB2505160A, Exp Date: 04/2027
Lot# CB2505161A, Exp Date: 05/2027
