FDA-Drug2026-02-04Class IIICHEMICAL
Novadoz Pharmaceuticals glycopyrrolate oral solution recalled for failed purity specifications
What this means
Novadoz Pharmaceuticals is recalling specific lots of glycopyrrolate oral solution (1 mg/5 mL) because the medication failed quality testing for impurities and degradation. The affected lots may not meet safety and effectiveness standards. Three lots are involved, with expiration dates between April and May 2027.
- Check your glycopyrrolate bottle for lot number CB2505159A, CB2505160A, or CB2505161A
- Do not use the medication if it matches one of these lots
- Contact your pharmacist or doctor for a replacement or alternative medication
- Return the recalled medication to your pharmacy
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
N/A
Manufactured in
20 Duke Rd Ste A, N/A, Piscataway, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0300-2026Want us to check the next one for you?
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