American Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
American Regent, Inc. is recalling specific lots of Cyanocobalamin injections due to the presence of 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 recall is classified as FDA Class II, and the presence of glass and particulate matter in an injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
American Regent, Inc. is recalling Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), for intramuscular or subcutaneous use. The recall affects 26,450 vials, including 10 mL Multi-Dose Vials (NDC 0517-0032-01) and 25x10 mL Multi-Dose Vials (NDC 0517-0032-25). The affected product is identified by Lot # 25082 with an expiration date of 3/31/2027.
The recall was initiated because the product was found to be contaminated with particulate matter. The specific contaminants identified include hair, glass, and/or paraformaldehyde. The product was distributed nationwide within the United States.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- CYANOCOBALAMIN (CYANOCOBALAMIN)
- Brand
- CYANOCOBALAMIN
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injectable Vitamin
- Affected units
- 26,450
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 #: 25082
- Exp. Date: 3/31/2027.
UPCs (2)
- 0305170031251
- 0305170032258
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CYANOCOBALAMIN
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- ModerateCyanocobalamin Injection Recalled for Subpotent Drug - Out of Specification Assay
FDA (Drugs) · 2022-04-20
- ModerateCardinal Health Recalls Cyanocobalamin Injection Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- SevereFresenius Kabi Recalls Cyanocobalamin Vials Due to Sterility Concerns
FDA (Drugs) · 2014-12-17
Same manufacturer · American Regent, Inc.
See all →- CriticalAmerican Regent Recalls Epinephrine Vials Due to Particulate Matter
FDA (Drugs) · 2026-09-16
- CriticalAmerican Regent Recalls Papaverine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Nitroglycerin Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Atropine Sulfate Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Selenious Acid Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
Same hazard · particulate matter
See all →- ModerateIMAAVY Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-10-14
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Similar recalls
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Nitroglycerin Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Acetylcysteine Solution Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAminocaproic Acid Injection Recalled for Particulate Matter Contamination
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Atropine Sulfate Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Selenious Acid Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26