American Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
American Regent, Inc. is recalling Cyanocobalamin injections because they contain particulate matter, including hair, glass, and paraformaldehyde.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. The presence of glass and paraformaldehyde in an injectable drug represents a significant injury risk, meeting the criteria for a Severe rating.
Plain-English summary
American Regent, Inc. is recalling Cyanocobalamin injection USP, 1,000 mcg/mL, packaged in 1 mL and 25x1 mL multi-dose vials. The recall affects 235,350 vials distributed nationwide within the U.S. The specific lots involved are 24297 (Exp. Date 8/31/2026) and 24364 (Exp. Date 10/31/2026).
The recall was initiated because the product is contaminated with particulate matter identified as hair, glass, and/or paraformaldehyde. This contamination poses a risk to patients receiving the medication via intramuscular or subcutaneous injection.
Healthcare providers and patients should stop using the affected vials and contact American Regent, Inc. for further instructions or returns.
The recalled product
- Product
- CYANOCOBALAMIN (CYANOCOBALAMIN)
- Brand
- CYANOCOBALAMIN
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injectable Vitamin
- Affected units
- 235,350
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 (4)
- Lot #: 24297
- Exp. Date 8/31/2026
- 24364
- Exp. Date: 10/31/2026
UPCs (2)
- 0305170031251
- 0305170032258
Distribution
Distributed nationwide across the United States.
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