Glycopyrrolate Oral Solution Recalled Due to Degradation Specification Failure

Key Takeaways

• The US Food and Drug Administration (FDA) is monitoring a voluntary, firm-initiated Class III recall of glycopyrrolate oral solution, 1 mg/5 mL, involving multiple lots (CB2505159A, CB2505160A, CB2505161A) with expiration dates in April and May 2027, distributed nationwide.
• The recall was initiated by Novadoz Pharmaceuticals LLC after the product failed impurities/degradation specifications, a quality issue not expected to cause adverse health consequences.
• Glycopyrrolate oral solution is an anticholinergic agent indicated to reduce salivary and respiratory secretions, commonly used in pediatric and surgical care settings.

The US Food and Drug Administration (FDA) has classified a Class III recall for Glycopyrrolate Oral Solution, 1 mg/5 mL, in 16 oz. (473 mL) bottles, following a failure to meet impurities and degradation specifications during routine testing. The product, labeled under NDC 72205-070-72, was manufactured by MSN Pharmaceuticals Inc. and distributed by Novadoz Pharmaceuticals LLC, both based in Piscataway, NJ. The recall involves multiple lots—CB2505159A, CB2505160A (Exp. 04/2027) and CB2505161A (Exp. 05/2027)—and was initiated on December 15, 2025, with distribution across the US nationwide.

The FDA designated this as a Class III recall on January 28, 2026, meaning the product defect is unlikely to cause adverse health consequences, but still constitutes a violation of FDA manufacturing quality standards. The recall was voluntarily initiated by the firm, and consignees were notified via letter. No injuries or adverse events have been reported. While the specific impurity or degradation compound was not named, exceeding specification limits can compromise drug stability and shelf life.

Glycopyrrolate is an anticholinergic agent used to reduce secretions in the mouth, throat, and airways, often administered before surgery or for chronic drooling (sialorrhea) in pediatric or neurologically impaired populations. Pharmacists should verify and remove affected lots from inventory and coordinate with prescribers to ensure patients receive replacement stock or unaffected alternatives. Though this recall presents minimal clinical risk, it is important to uphold drug quality assurance, particularly in long-term or pediatric use cases.

Reference
FDA. Enforcement Report. January 28, 2026. Accessed January 29, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm