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FDA · Class I · August 26, 2026

American Regent recall: Nitroglycerin injection and 9 more products

American Regent, Inc. is recalling Nitroglycerin injection and 9 more products – 98,200 vials; 235,350 vials; 26,450 vials; 63,200 vials; 89,775 vials; 316,450 vials; 169,200 vials; 41,680 vials; 185,775 vials; 86,100 vials; 323,000 vials; 43,460 vials. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 24, 2026. Distributed nationwide.

Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.

A pharmacy dispensing machine
Illustration: A pharmacy dispensing machine – not the recalled product. Photo: U.S. Air Force / Airman Trevor Calvert, public domain.
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ProductNitroglycerin injection and 9 more products
BrandAmerican Regent
CompanyAmerican Regent, Inc.
TypeDrugs
ClassificationClass I
Recall dateJuly 24, 2026
Published by FDAAugust 26, 2026
Quantity98,200 vials; 235,350 vials; 26,450 vials; 63,200 vials; 89,775 vials; 316,450 vials; 169,200 vials; 41,680 vials; 185,775 vials; 86,100 vials; 323,000 vials; 43,460 vials
Recall ID99503
As listed by FDA

Recalled products (12)

  1. 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.
    FDA recall number
    D-0791-2026
    Codes, lots and dates
    Lot #: 24291, Exp. Date: 8/31/2026
    Quantity
    98,200 vials
    Classification
    Class II
  2. Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
    FDA recall number
    D-0792-2026
    Codes, lots and dates
    Lot #: 24297, Exp. Date 8/31/2026; 24364, Exp. Date: 10/31/2026;
    Quantity
    235,350 vials
    Classification
    Class II
  3. Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
    FDA recall number
    D-0793-2026
    Codes, lots and dates
    Lot #: 25082, Exp. Date: 3/31/2027.
    Quantity
    26,450 vials
    Classification
    Class II
  4. AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.
    FDA recall number
    D-0794-2026
    Codes, lots and dates
    Lot #: 24299, Exp. Date: 8/31/2026.
    Quantity
    63,200 vials
    Classification
    Class II
  5. Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967.
    FDA recall number
    D-0795-2026
    Codes, lots and dates
    Lot #: 24353, Exp. Date: 9/30/2026.
    Quantity
    89,775 vials
    Classification
    Class II
  6. ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
    FDA recall number
    D-0796-2026
    Codes, lots and dates
    Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027
    Quantity
    316,450 vials
    Classification
    Class II
  7. ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
    FDA recall number
    D-0797-2026
    Codes, lots and dates
    Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.
    Quantity
    169,200 vials
    Classification
    Class II
  8. Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
    FDA recall number
    D-0798-2026
    Codes, lots and dates
    Lot #: 25090, Exp. Date 2/28/2027.
    Quantity
    41,680 vials
    Classification
    Class II
  9. Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
    FDA recall number
    D-0799-2026
    Codes, lots and dates
    Lot #: 25163, Exp. Date: 4/30/2027.
    Quantity
    185,775 vials
    Classification
    Class II
  10. Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
    FDA recall number
    D-0800-2026
    Codes, lots and dates
    Lot #: 25202, Exp. Date: 11/30/2026.
    Quantity
    86,100 vials
    Classification
    Class I
  11. Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
    FDA recall number
    D-0801-2026
    Codes, lots and dates
    Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.
    Quantity
    323,000 vials
    Classification
    Class II
  12. 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.
    FDA recall number
    D-0802-2026
    Codes, lots and dates
    Lot #: 25295N0C0, Exp. Date: 04/30/2027.
    Quantity
    43,460 vials
    Classification
    Class II
Exactly as the agency lists them

Identifiers and details

FDA event ID
99503
Initiated
Voluntary: Firm initiated
Status
Ongoing
Firm location
Shirley, NY, United States

Why it was recalled

The reason the FDA lists: “Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde / Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde”

Where it was sold

Nationwide. Distribution as the FDA records it: “Nationwide within the U.S”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99503, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

Same brand

Other American Regent recalls

DateRecallProblemAgency
Sep 16, 2026American Regent recall: Epinephrine InjectionDrugs · 31,935 30mL-vialsa sterility problem
Most serious		FDA
Class I
Latest

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DateRecallProblemAgency
Oct 7, 2026Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugsFailed Dissolution Specifications: below specification
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Oct 7, 2026Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottlesCrystallization
Serious		FDA
Class II
Oct 7, 2026Apotex recall: Paroxetine Extended-Release TabletsDrugsFailed dissolution specifications.
Serious		FDA
Class II
Oct 7, 2026TerSera Therapeutics recall: ZoladexDrugs · 296 cartonsTemperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou…
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Oct 7, 2026Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottlesa sterility problem
Serious		FDA
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Oct 7, 2026Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartonsDefective Container; packets were found to be either empty or partially full.
Serious		FDA
Class II
FAQ

About this recall

Is American Regent Nitroglycerin injection recalled?

Yes. American Regent, Inc. recalled it on July 24, 2026; FDA published it August 26, 2026 (Class I). Only the lots, dates or models listed on this page are included.

Why was it recalled?

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde / Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

What should I do if I have it?

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.

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