FDA-Drug2026-08-26Class IIPROCESSING DEFECT
American Regent niCARdipine Hydrochloride Injection recalled for particulate contamination
What this means
American Regent's niCARdipine Hydrochloride Injection (25 mg/10mL) has been recalled due to contamination with particulate matter, including hair, glass, and/or paraformaldehyde. The affected lot (25295N0C0, expiring 04/30/2027) was distributed nationwide and affects approximately 43,460 vials.
- If you have received this medication, do not use it.
- Contact your healthcare provider or pharmacy immediately for guidance.
- Return the product to your pharmacy or healthcare facility.
- Check lot number 25295N0C0 on your vial; discard if it matches.
The agency's original wording
Hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
43,460 vials
Manufactured in
5 Ramsay Rd, Shirley, NY, United States
Products
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), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0802-2026More American Regent recalls
- FDA-Drug2026-09-16American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-PR2026-09-03American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-Drug2026-08-26American Regent Cyanocobalamin injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent Tralement trace elements injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent aminocaproic acid injection recalled for particulate contamination
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