Glycopyrrolate Oral Solution recall (NOVADOZ PHARMACEUTICALS LLC)
DrugClass IIIOngoing
Summary: NOVADOZ PHARMACEUTICALS LLC is recalling 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: Failed Impurities/Degradation Specifications.
What is being recalled
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
Failed Impurities/Degradation Specifications
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0300-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | December 15, 2025 |
| Reported | February 4, 2026 |
| Company | NOVADOZ PHARMACEUTICALS LLC |
| Company location | Piscataway, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | N/A |
More recalls from NOVADOZ PHARMACEUTICALS LLC · all drug recalls · recalls from December 2025