American Regent Recalls Cyanocobalamin Injection Due to Particulate Matter
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American Regent, Inc. is recalling 26,450 vials of Cyanocobalamin injection after contamination with particulate matter including hair, glass, and paraformaldehyde was identified.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
American Regent, Inc. initiated a voluntary recall of Cyanocobalamin injection USP due to the presence of particulate matter identified as hair, glass and/or paraformaldehyde.
Which Products Are Affected
Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25). Lot #: 25082, Exp. Date: 3/31/2027. A total of 26,450 vials are affected. Distributed nationwide within the U.S.
What You Should Do
Consumers and healthcare providers should follow guidance from the recalling firm regarding the affected product.
Why This Matters
This Class II recall involves a human prescription drug distributed nationwide, with potential for temporary or reversible adverse health consequences.
Source
FDA recall number D-0793-2026. American Regent, Inc., Shirley, NY.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (920 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.