FDA Recall D-0300-2026
NOVADOZ PHARMACEUTICALS LLC · Piscataway, NJ
Class III Ongoing 150 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Failed Impurities/Degradation Specifications
Recall record
- Recall number
D-0300-2026- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide.
- Recall initiated
- 2025-12-15
- Classified by FDA Center
- 2026-01-28
- FDA published
- 2026-02-04
- Recalling firm
- NOVADOZ PHARMACEUTICALS LLC
- Firm location
- Piscataway, NJ
Drug identification
- Brand name(s)
- GLYCOPYRROLATE
- Generic name(s)
- GLYCOPYRROLATE
- Manufacturer(s)
- Novadoz Pharmaceuticals LLC
- NDC(s)
72205-070- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.