Nicardipine Hydrochloride Injection Recall Due to Particulate Matter

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

American Regent, Inc. is recalling 43,460 vials of niCARdipine Hydrochloride Injection, USP due to contamination with particulate matter.

Reading this FDA recall beyond the headline

This notice was issued by FDA on September 7, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde", distributed nationwide within the u.s. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. 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.

It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.

The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, fda, Drugs.

What Happened

The recall was initiated due to the presence of particulate matter identified as hair, glass and/or paraformaldehyde in the product.

Which Products Are Affected

niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10). Lot #: 25295N0C0, Exp. Date: 04/30/2027. A total of 43,460 vials are affected. The recalling firm is American Regent, Inc. Distribution was nationwide within the U.S.

What You Should Do

This is a voluntary recall initiated by the firm. Consumers should consult their healthcare provider regarding the affected product.

Why This Matters

The Class II recall involves a human prescription drug distributed nationwide.

Source

FDA recall number D-0802-2026

Original source: FDA Official Notice ↗

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Comparable nationwide notices (length or severity timing) 8

Two cross-category peer sets, both computed from Areazine's own archive: notices with a similar body length, and notices near the same severity and agency date. These are drawn from other categories, not the same-feed Related list above.

Frequently Asked Questions

What people usually ask about a notice like this one.

What is this FDA recall about?
American Regent, Inc. is recalling 43,460 vials of niCARdipine Hydrochloride Injection, USP due to contamination with particulate matter.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter?
The FDA classifies this as a Class II recall, citing "Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde" as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.