FDA recall, , High risk
American Regent Nitroglycerin, Cyanocobalamin, Aminocaproic Acid, Atropine Sulfate, Acetylcysteine, Selenious Acid, Multrys, Papaverine HCl, Tralement and Nicardipine Injections
American Regent injections contain particulate matter.
Summary by Recall Canary from the FDA notice
What happened
American Regent, Inc., of Shirley, New York, is conducting a nationwide voluntary recall of multiple injectable products due to the presence of particulate matter identified as hair, glass and/or paraformaldehyde.
The affected products include Tralement, Cyanocobalamin injection USP, Multrys, Aminaocaproic Acid Injection, Selenious Acid Injection, Acetylcysteine Solution, Atropine Sulfate injection, niCARdipine Hydrochloride Injection, Nitroglycerin injection, and Papaverine HCl Injection. The recall began on July 24, 2026, and was added to the FDA's Enforcement Report on August 17, 2026.
2 photos
What to do
If a code on your package is listed below:
- Distributors/retailers/healthcare facilities that have the product which is being recalled should stop using and return to place of purchase or discard the product.
- Consumers and healthcare professionals with questions regarding this recall can contact American Regent Inc. using the below information.
- Patients that use this product which is being recalled should stop using them and contact their doctor or health care provider.
- Contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this drug product.
Is yours affected?
12 products
Match the list below, then check the codes the FDA notice also names.
An NDC (National Drug Code) is usually printed on the drug's label.
Selenious Acid Injection, USP
- Strength
- 12 mcg
- NDC
- 0517-6502-01
- 0517-6502-10
- Lot code
- 25090
Papaverine Hydrochloride Injection, USP 60 mg/2 mL Single dose vial
- NDC
- 0517-4002-25
- Lot code
- 25202
- Best-by or expiration date
- 11/30/2026 Distribution Dates: 9/30/2025
Tralement (trace elements injection 4*, USP)
- NDC
- 0517-9305-01
- 0517-9305-25
- Lot code
- 25149
- 25371
Cyanocobalamin injection USP, 1
- Strength
- 000 mcg/mL
- NDC
- 0517-0031-01
- 0517-0031-25
- Lot code
- 24297
Multrys (Trace Elements Injection 4, USP), For intravenous infusion
- NDC
- 0517-9302-01
- 0517-9302-25
- Lot code
- 25163
Aminaocaproic Acid Injection, USP
- Strength
- 250 mg/mL
- NDC
- 0517-9120-01
- 0517-9120-25
- Lot code
- 24299
Cyanocobalamin injection USP, 10
- Strength
- 000 mcg
- NDC
- 0517-0032-01
- 0517-0032-25
- Lot code
- 25082
Acetylcysteine Solution, USP, 20% (
- Strength
- 200 mg/mL
- NDC
- 0517-7604-01
- 0517-7604-25
- Lot code
- 24426
Acetylcysteine Solution, USP, 10% (
- Strength
- 100 mg/mL
- NDC
- 0517-7504-01
- 0517-7504-25
- Lot code
- 24418
Atropine Sulfate injection, USP
- Strength
- 1 mg/mL
- NDC
- 0517-1001-01
- 0517-1001-25
- Lot code
- 24353
niCARdipine Hydrochloride Injection, USP
- Strength
- 25 mg
- NDC
- 72572-470-01
- 72572-470-10
- Lot code
- 25295N0C0
Nitroglycerin injection, USP
- Strength
- 50 mg
- NDC
- 0517-4810-01
- 0517-4810-25
- Lot code
- 24291
From the FDA notice
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.
Recall details
- Company began the recall
- Sold in
Nationwide within the U.S
- Company
- American Regent, Inc.Shirley, New York
- Hazard
- Contamination
- Risk
High risk
There is a reasonable chance that taking it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99503
- Recall numbers
- D-0791-2026 to D-0802-2026
All recalls from American Regent, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall · Announced by the company
Listed on Recall Canary
Added to FDA's Enforcement Report
Classified by FDA · In FDA's weekly enforcement report
Summary updated
