FDARecall 99503Medicines
What to do
The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.
Read the official notice on accessdata.fda.gov (opens in a new tab)
Hazard
Why it was 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
FDA classification: Class I. FDA’s highest class: a reasonable probability that using the product will cause serious health consequences or death. Status: Ongoing.
Is it yours? Products and codes
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.
- Lot or code
- Lot #: 24291, Exp. Date: 8/31/2026
- FDA recall number
- D-0791-2026
- Quantity
- 98,200 vials
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.
- Lot or code
- Lot #: 24297, Exp. Date 8/31/2026; 24364, Exp. Date: 10/31/2026;
- FDA recall number
- D-0792-2026
- Quantity
- 235,350 vials
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.
- Lot or code
- Lot #: 25082, Exp. Date: 3/31/2027.
- FDA recall number
- D-0793-2026
- Quantity
- 26,450 vials
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.
- Lot or code
- Lot #: 24299, Exp. Date: 8/31/2026.
- FDA recall number
- D-0794-2026
- Quantity
- 63,200 vials
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.
- Lot or code
- Lot #: 24353, Exp. Date: 9/30/2026.
- FDA recall number
- D-0795-2026
- Quantity
- 89,775 vials
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.
- Lot or code
- Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027
- FDA recall number
- D-0796-2026
- Quantity
- 316,450 vials
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.
- Lot or code
- Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.
- FDA recall number
- D-0797-2026
- Quantity
- 169,200 vials
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.
- Lot or code
- Lot #: 25090, Exp. Date 2/28/2027.
- FDA recall number
- D-0798-2026
- Quantity
- 41,680 vials
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.
- Lot or code
- Lot #: 25163, Exp. Date: 4/30/2027.
- FDA recall number
- D-0799-2026
- Quantity
- 185,775 vials
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.
- Lot or code
- Lot #: 25202, Exp. Date: 11/30/2026.
- FDA recall number
- D-0800-2026
- Quantity
- 86,100 vials
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.
- Lot or code
- Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.
- FDA recall number
- D-0801-2026
- Quantity
- 323,000 vials
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.
- Lot or code
- Lot #: 25295N0C0, Exp. Date: 04/30/2027.
- FDA recall number
- D-0802-2026
- Quantity
- 43,460 vials
Distribution (FDA): Nationwide within the U.S
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- American Regent, Inc. (other notices of this firm)
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.