FDA recall, , Low risk
Novadoz Glycopyrrolate Oral Solution
Glycopyrrolate Oral Solution failed impurities and degradation specifications.
Summary by Recall Canary from the FDA notice
What happened
NOVADOZ PHARMACEUTICALS LLC of Piscataway, New Jersey, recalled Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, because it failed impurities and degradation specifications. The product was distributed nationwide by Novadoz Pharmaceuticals LLC and manufactured by MSN Pharmaceuticals Inc., Piscataway, NJ 08854. The recall began December 15, 2025.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 72205-070-72
- Lot code
- CB2505159A
- CB2505160A
- CB2505161A
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- NOVADOZ PHARMACEUTICALS LLCPiscataway, New Jersey
- Hazard
- Drug impurity
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98156
- Recall number
- D-0300-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
