FDA-Drug2026-08-26Class IIPROCESSING DEFECT
American Regent nitroglycerin injection recalled for particulate contamination
What this means
American Regent's nitroglycerin injection (50 mg/10 mL vials) has been found to contain particulate matter, including hair, glass, and/or paraformaldehyde. This affects lot #24291 with an expiration date of 8/31/2026, distributed nationwide. The contamination was discovered during quality testing.
- If you have nitroglycerin injection NDC 0517-4810-01 or 0517-4810-25 from lot #24291, do not use it.
- Contact your pharmacy or healthcare provider immediately to confirm whether you have affected product.
- Your provider can supply an alternative or unaffected nitroglycerin injection.
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
98,200 vials
Manufactured in
5 Ramsay Rd, Shirley, NY, United States
Products
Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0791-2026More 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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