Papaverine HCl Injection Recall Due to Particulate Matter
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American Regent, Inc. is recalling 86,100 vials of Papaverine HCl Injection, USP due to contamination with glass and/or paraformaldehyde particulate matter.
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 "high" 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. has initiated a voluntary recall of Papaverine HCl Injection, USP after the product was found contaminated with particulate matter identified as glass and/or paraformaldehyde.
Which Products Are Affected
The recall covers Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL) in 2mL Single-Dose Vials (NDC 0517-4002-01) and 25x2mL Single-Dose Vials (NDC 0517-4002-25). Affected lot is 25202 with expiration date 11/30/2026. A total of 86,100 vials are involved. Distribution was nationwide within the U.S.
What You Should Do
Consumers and healthcare providers should stop using the affected product and contact the recalling firm for return or refund instructions.
Why This Matters
This is a Class I recall, indicating a reasonable probability of serious adverse health consequences or death.
Source
FDA recall number D-0800-2026; 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 (high) notices issued closest in time to September 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.