American Regent, Inc. drug recall: Nitroglycerin injection

Reason for recall

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 the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
• Class II: Using or being exposed to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

About this recall

The firm started this recall on Jul 24, 2026. FDA classified it 33 days later, on Aug 26, 2026. This recall event covers 12 separate products, each with its own FDA recall number. Distribution reported by FDA: Nationwide within the U.S American Regent, Inc. has 7 recalls in our records.

Recalled products (12)

• D-0791-2026 Class II Ongoing

  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.

  Codes / lots: Lot #: 24291, Exp. Date: 8/31/2026

  Quantity: 98,200 vials

• D-0792-2026 Class II Ongoing

  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.

  Codes / lots: Lot #: 24297, Exp. Date 8/31/2026; 24364, Exp. Date: 10/31/2026;

  Quantity: 235,350 vials

• D-0793-2026 Class II Ongoing

  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.

  Codes / lots: Lot #: 25082, Exp. Date: 3/31/2027.

  Quantity: 26,450 vials

• D-0794-2026 Class II Ongoing

  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.

  Codes / lots: Lot #: 24299, Exp. Date: 8/31/2026.

  Quantity: 63,200 vials

• D-0795-2026 Class II Ongoing

  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.

  Codes / lots: Lot #: 24353, Exp. Date: 9/30/2026.

  Quantity: 89,775 vials

• D-0796-2026 Class II Ongoing

  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.

  Codes / lots: Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027

  Quantity: 316,450 vials

• D-0797-2026 Class II Ongoing

  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.

  Codes / lots: Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.

  Quantity: 169,200 vials

• D-0798-2026 Class II Ongoing

  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.

  Codes / lots: Lot #: 25090, Exp. Date 2/28/2027.

  Quantity: 41,680 vials

• D-0799-2026 Class II Ongoing

  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.

  Codes / lots: Lot #: 25163, Exp. Date: 4/30/2027.

  Quantity: 185,775 vials

• D-0800-2026 Class I Ongoing

  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.

  Codes / lots: Lot #: 25202, Exp. Date: 11/30/2026.

  Quantity: 86,100 vials

• D-0801-2026 Class II Ongoing

  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.

  Codes / lots: Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.

  Quantity: 323,000 vials

• D-0802-2026 Class II Ongoing

  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.

  Codes / lots: Lot #: 25295N0C0, Exp. Date: 04/30/2027.

  Quantity: 43,460 vials