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Stop using now Drug recall · FDA · Published July 24, 2026

American Regent ACETYLCYSTEINE Solution Recall: Particulate Matter Hazard

American Regent recalls 10% acetylcysteine solution vials due to contamination with hair, glass, and paraformaldehyde. Stop using if you have these vials.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0796-2026DrugAmerican Regent ›
Official FDA recall photos · click to enlarge
✎ GovInfoNow plain-language explainer

American Regent is recalling acetylcysteine solution vials that may contain hair, glass, or paraformaldehyde particles. This contamination could cause serious injury if the product is used. Read more at govinfonow.com/recall/692896-american-regent-acetylcysteine-solution-recall-particulate-matter-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/692896-american-regent-acetylcysteine-solution-recall-particulate-matter-hazard · Updated September 14, 2026 · FDA enforcement record: FDA #D-0796-2026

Cite this page

“American Regent ACETYLCYSTEINE Solution Recall: Particulate Matter Hazard.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/692896-american-regent-acetylcysteine-solution-recall-particulate-matter-hazard. Based on FDA recall #D-0796-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0796-2026%22&limit=1).

The FDA announced on July 24, 2026, that American Regent, Inc. is recalling ACETYLCYSTEINE SOLUTION, USP, 10% due to the presence of particulate matter including hair, glass, and paraformaldehyde. According to the FDA, owners should stop using the product immediately.

How to tell if you have it

  • Brand: American Regent
  • Product: ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL)
  • Packaging: a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25)
  • Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027
  • Units affected: 316,450 vials

The hazard

The product is contaminated with particulate matter identified as hair, glass and/or paraformaldehyde. The FDA classified this recall as Class II.

Context

GovInfoNow's records show American Regent, Inc. has 6 other recalls on record since May 13, 2024. Other recent recalls of similar products include Radnostix Sodium Iodide Solution Recall (January 26, 2026), Apollo Care SEMAGLUTIDE Vial Recall (July 29, 2026) and Mallinckrodt Acthar Gel 5mL Vial Recall (August 6, 2026).

How to tell if you have this one

Check for vials labeled 'ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL)' with NDC numbers 0517-7504-01 or 0517-7504-25. The product is prescription-only and sold by American Regent in Shirley, NY.

  • Brand
    American Regent
  • Category
    Drug
FDA recall event · 12 products

All 12 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Status
    Ongoing
  • Distribution
    Nationwide within the U.S
Recall numberProduct, codes & lotsQuantityClass
D-0791-2026Nitroglycerin 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.; Lot #: 24291, Exp. Date: 8/31/202698,200 vialsClass II
D-0792-2026Cyanocobalamin 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.; Lot #: 24297, Exp. Date 8/31/2026; 24364, Exp. Date: 10/31/2026;235,350 vialsClass II
D-0793-2026Cyanocobalamin 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.; Lot #: 25082, Exp. Date: 3/31/2027.26,450 vialsClass II
D-0794-2026AMINAOCAPROIC 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.; Lot #: 24299, Exp. Date: 8/31/2026.63,200 vialsClass II
D-0795-2026Atropine 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.; Lot #: 24353, Exp. Date: 9/30/2026.89,775 vialsClass II
D-0796-2026ACETYLCYSTEINE 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.; Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027316,450 vialsClass II
D-0797-2026ACETYLCYSTEINE 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.; Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.169,200 vialsClass II
D-0798-2026Selenious 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.; Lot #: 25090, Exp. Date 2/28/2027.41,680 vialsClass II
D-0799-2026Multrys (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.; Lot #: 25163, Exp. Date: 4/30/2027.185,775 vialsClass II
D-0800-2026Papaverine 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.; Lot #: 25202, Exp. Date: 11/30/2026.86,100 vialsClass I
D-0801-2026Tralement (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.; Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.323,000 vialsClass II
D-0802-2026niCARdipine 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.; Lot #: 25295N0C0, Exp. Date: 04/30/2027.43,460 vialsClass II
Based on the official FDA remedy

What to do — step by step

  1. Stop using it now

    Immediately discard any recalled acetylcysteine solution vials that may contain particulate matter.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the U.S” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 33 days after the firm started it.

1. Firm started the recall: Jul 24, 202612. FDA classified it Class II: Aug 26, 202623. Published in FDA’s Enforcement Report: Aug 26, 202634. Added to GovInfoNow: Sep 8, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0796-2026 (July 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0796-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA