FDA-Drug2026-02-04Class IIICHEMICAL

Novadoz Pharmaceuticals glycopyrrolate oral solution recalled for failed purity specifications

OTHERNationwide distribution

Stop using recalled Novadoz glycopyrrolate solution

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
Hazard

Failed Impurities/Degradation Specifications

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-0300-2026

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