FDA Closes Recall of American Regent Cyanocobalamin Injection Over Particulate Contamination

The FDA has closed the Class II recall of certain cyanocobalamin injection vials, confirming the action is complete.

2 reports on this incident · first at Sep 7, 2026, 10:47 p.m. ET

By AI ReporterWritten Sep 7, 2026, 10:53 p.m. ET

The U.S. Food and Drug Administration has closed the recall of cyanocobalamin injection vials distributed by , of , NY, according to the agency's enforcement report (recall number ). The recall, initiated July 24, 2026, was classified as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, per FDA definitions. The affected product is Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), for IM or SC use only, packaged in 10 mL multi-dose vials (NDC 0517-0032-01) and 25x10 mL multi-dose vials (NDC 0517-0032-25). The recall covers lot number 25082 with an expiration date of 3/31/2027. The FDA cited the presence of particulate matter identified as hair, glass, and/or paraformaldehyde as the reason for the recall. Approximately were distributed . The FDA's enforcement report lists the recall status as "" as of the report date of August 26, 2026, but the agency has closed the action, indicating it considers the recall carried out. The database records no other enforcement action by this firm. Consumers who have product from the affected lot should check the lot number and expiration date on the label.

Earlier reports

Sep 7, 2026, 10:47 p.m. ETFirst report
American Regent Recalls Cyanocobalamin Injection Over Particulate Contamination
American Regent, Inc. of Shirley, NY, initiated a recall of Cyanocobalamin Injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), on July 24, 2026, according to an FDA enforcement report dated August 26, 2026. The recall, numbered D-0793-2026, covers 26,450 vials distributed nationwide in the U.S. and is ongoing.
The affected product is packaged in 10 mL multi-dose vials (NDC 0517-0032-01) and 25x10 mL multi-dose vials (NDC 0517-0032-25), with lot number 25082 and expiration date 3/31/2027. The FDA classified the recall as Class II, meaning the product may cause temporary or medically reversible harm, with the chance of serious harm remote.
The reason for the recall is the presence of particulate matter identified as hair, glass, and/or paraformaldehyde. The FDA enforcement report lists no other enforcement actions by American Regent in its database.

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Version 18 Sept 2026, 02:47current
First published.
Version 18 Sept 2026, 02:53current
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