Glycopyrrolate Injection Recall Due to Hair Contamination
Fresenius Kabi is recalling Glycopyrrolate Injection due to the presence of particulate matter, specifically hair found in the product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving particulate matter (hair) in an injectable drug product. No illnesses or injuries have been reported, and the contamination is classified as a moderate risk rather than a high-risk pathogen or allergen mislabeling.
Plain-English summary
Fresenius Kabi USA, LLC is recalling Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), packaged in multiple dose vials. The product was distributed nationwide within the USA in tray and vial configurations under NDC numbers 633323-578-05 and 633323-578-07.
The recall is being issued due to the presence of particulate matter, specifically hair found in the product. The affected lots are 6134349 and 6134620 with an expiration date of November 2026.
Healthcare facilities and pharmacies that received the affected product should immediately check their inventory, quarantine any remaining units, and contact Fresenius Kabi to arrange for return or replacement. The total quantity involved in the recall is 59,425 vials.
No adverse events or injuries have been reported in connection with this recall. Consumers or healthcare providers with questions should contact Fresenius Kabi USA, LLC directly.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injection / Injectable
- Affected units
- 59,425
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 6134349
- 6134620 Exp. Date 11/2026
UPCs (3)
- 0363323578046
- 0363323578039
- 0363323578077
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Fresenius Kabi USA, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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