Recalls / Class III
Class IIID-0300-2026
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
- Brand name
- Glycopyrrolate
- Generic name
- Glycopyrrolate
- Active ingredient
- Glycopyrrolate
- Route
- Oral
- NDC
- 72205-070
- FDA application
- ANDA216084
- Affected lot / code info
- Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- NOVADOZ PHARMACEUTICALS LLC
- Manufacturer
- Novadoz Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Duke Rd Ste A, N/A, Piscataway, New Jersey 08854-3714
Distribution
- Quantity
- N/A
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-12-15
- FDA classified
- 2026-01-28
- Posted by FDA
- 2026-02-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0300-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.