Glycopyrrolate Injection Recalled Due to the Presence of Particulate Matter
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for glycopyrrolate injections, 1 mg/5 mL (0.2 mg/mL). The affected batches have been identified as Lots 6134349 and 6134620 (expiration November 2026), affecting 59 425 vials.
- The recall was initiated by Fresenius Kabi USA, LLC due to the presence of particulate matter, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
- Glycopyrrolate injections are used during surgery to reduce saliva and stomach acid, prevent heart rhythm problems, and prevent physical reactions. They can also be used to treat the symptoms of peptic ulcers.
The FDA has issued a Class II recall for glycopyrrolate injections, 1 mg per 5 mL (0.2 mg per mL), affecting 59 425 vials. This product is being recalled by Fresenius Kabi USA, LLC based in Lake Zurich, Illinois. The recall was initiated on July 16, 2026, and received a Class II classification on July 23, 2026. A Class II recall indicates that use of or exposure to the product may cause temporary or medically reversible adverse health consequences or that the probability of serious adverse health consequences is remote.
The recall was initiated due to the presence of particulate matter; specifically, hair was identified in the product. This deficiency affects Lots 6134349 and 6134620, which will expire in November 2026. Fresenius Kabi USA sent out a public notice via letter; no press release has been issued for this recall.
Glycopyrrolate injections are used during surgical procedures to reduce the amount of saliva and stomach acid, prevent cardiac arrhythmias, and prevent reactions caused by certain medications. They can also be used to lessen symptoms caused by peptic ulcers. Pharmacists should identify and quarantine Lots 6134349 and 6134620, remove them from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
FDA. Enforcement Report. July 29, 2026. Accessed July 29, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221577
