Class II · Posted August 26, 2026 · Started August 7, 2026 · Ongoing
carbamazepine
- Product
- Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed by: GSMS, Incorporated, Camarillo, CA 93012 USA
- Firm
- Golden State Medical Supply Inc., Camarillo, CA
- Reason
- CGMP deviations: tablets with black specks.
- Lots
- Lot #: a) GS067429, GS068091, Exp 5/31/2028; b) GS067430, GS068090, Exp 5/31/2028
- Quantity
- 1200 bottles
- Distribution
- USA Nationwide
- RxNorm
- carbamazepine (RxCUI 308979)
- Recall number
- D-0771-2026
Class I · Posted August 26, 2026 · Started August 4, 2026 · Ongoing
morphine sulfate
- Product
- Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11
- Firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Reason
- Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
- Lots
- Lot #: 6402820, Exp. Date 12/2028
- Quantity
- 625500 syringes
- Distribution
- Nationwide within the USA.
- RxNorm
- morphine sulfate (RxCUI 894912, 894914, 998212, 998213, 1442790, +1 more)
- Recall number
- D-0788-2026
Class II · Posted August 26, 2026 · Started August 3, 2026 · Ongoing
Carbamazepine Tablets
- Product
- Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Reason
- CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
- Lots
- Lot # AD94033, Exp Date: 5/31/2028.
- Quantity
- 1968 Bottles (1000Tablets/Bottle)
- Distribution
- US Nationwide.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0770-2026
Class II · Posted August 26, 2026 · Started July 29, 2026 · Ongoing
pemetrexed disodium
- Product
- PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1
- Firm
- Shilpa Medicare Limited, Jadcherla, Mahabubnagar District, India
- Reason
- Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- Lots
- Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027
- Quantity
- 9,489 50mL vials
- Distribution
- Nationwide in the USA.
- RxNorm
- pemetrexed disodium (RxCUI 2637958, 2637964, 2637966, 2637967, 2637968, +1 more)
- Recall number
- D-0765-2026
Class II · Posted August 26, 2026 · Started July 29, 2026 · Ongoing
pemetrexed disodium
- Product
- PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1
- Firm
- Shilpa Medicare Limited, Jadcherla, Mahabubnagar District, India
- Reason
- Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- Lots
- Lot: P400172; Lot PA00050A, Exp 09/30/2027
- Quantity
- 18,434 10mL vials
- Distribution
- Nationwide in the USA.
- RxNorm
- pemetrexed disodium (RxCUI 2637958, 2637964, 2637966, 2637967, 2637968, +1 more)
- Recall number
- D-0764-2026
Class II · Posted August 26, 2026 · Started July 28, 2026 · Ongoing
cemiplimab-rwlc
- Product
- Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01
- Firm
- Regeneron Pharmaceuticals Inc, Tarrytown, NY
- Reason
- Lack of Assurance of Sterility
- Lots
- Lot: 8494000002, Exp 7/31/28
- Quantity
- 21,353 vials
- Distribution
- USA Nationwide
- RxNorm
- cemiplimab-rwlc (RxCUI 2058830, 2058835)
- Recall number
- D-0767-2026
Class II · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
nicardipine hydrochloride
- Product
- 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.
- Firm
- American Regent, Inc., Shirley, NY
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lots
- Lot #: 25295N0C0, Exp. Date: 04/30/2027.
- Quantity
- 43,460 vials
- Distribution
- Nationwide within the U.S
- RxNorm
- nicardipine hydrochloride (RxCUI 858607)
- Recall number
- D-0802-2026
Class II · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
trace elements injection 4
- Product
- 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.
- Firm
- American Regent, Inc., Shirley, NY
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lots
- Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.
- Quantity
- 323,000 vials
- Distribution
- Nationwide within the U.S
- RxNorm
- trace elements injection 4 (RxCUI 2693627, 2693633)
- Recall number
- D-0801-2026
Class I · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
papaverine hydrochloride
- Product
- 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.
- Firm
- American Regent, Inc., Shirley, NY
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
- Lots
- Lot #: 25202, Exp. Date: 11/30/2026.
- Quantity
- 86,100 vials
- Distribution
- Nationwide within the U.S
- RxNorm
- papaverine hydrochloride (RxCUI 1789947)
- Recall number
- D-0800-2026
Class II · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
trace elements injection 4
- Product
- 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.
- Firm
- American Regent, Inc., Shirley, NY
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lots
- Lot #: 25163, Exp. Date: 4/30/2027.
- Quantity
- 185,775 vials
- Distribution
- Nationwide within the U.S
- RxNorm
- trace elements injection 4 (RxCUI 2568573, 2568579)
- Recall number
- D-0799-2026
Class II · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
selenious acid
- Product
- 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.
- Firm
- American Regent, Inc., Shirley, NY
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lots
- Lot #: 25090, Exp. Date 2/28/2027.
- Quantity
- 41,680 vials
- Distribution
- Nationwide within the U.S
- RxNorm
- selenious acid (RxCUI 2176324, 2591522)
- Recall number
- D-0798-2026
Class II · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
acetylcysteine
- Product
- 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.
- Firm
- American Regent, Inc., Shirley, NY
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lots
- Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.
- Quantity
- 169,200 vials
- Distribution
- Nationwide within the U.S
- RxNorm
- acetylcysteine (RxCUI 307718, 307719)
- Recall number
- D-0797-2026
Class II · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
acetylcysteine
- Product
- 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.
- Firm
- American Regent, Inc., Shirley, NY
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lots
- Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027
- Quantity
- 316,450 vials
- Distribution
- Nationwide within the U.S
- RxNorm
- acetylcysteine (RxCUI 307718, 307719)
- Recall number
- D-0796-2026
Class II · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
atropine sulfate
- Product
- 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.
- Firm
- American Regent, Inc., Shirley, NY
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lots
- Lot #: 24353, Exp. Date: 9/30/2026.
- Quantity
- 89,775 vials
- Distribution
- Nationwide within the U.S
- RxNorm
- atropine sulfate (RxCUI 1190795, 1666781)
- Recall number
- D-0795-2026
Class II · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
aminocaproic acid
- Product
- 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.
- Firm
- American Regent, Inc., Shirley, NY
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lots
- Lot #: 24299, Exp. Date: 8/31/2026.
- Quantity
- 63,200 vials
- Distribution
- Nationwide within the U.S
- RxNorm
- aminocaproic acid (RxCUI 238719)
- Recall number
- D-0794-2026
Class II · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
cyanocobalamin
- Product
- 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.
- Firm
- American Regent, Inc., Shirley, NY
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lots
- Lot #: 25082, Exp. Date: 3/31/2027.
- Quantity
- 26,450 vials
- Distribution
- Nationwide within the U.S
- RxNorm
- cyanocobalamin (RxCUI 309594)
- Recall number
- D-0793-2026
Class II · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
cyanocobalamin
- Product
- 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.
- Firm
- American Regent, Inc., Shirley, NY
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lots
- Lot #: 24297, Exp. Date 8/31/2026; 24364, Exp. Date: 10/31/2026;
- Quantity
- 235,350 vials
- Distribution
- Nationwide within the U.S
- RxNorm
- cyanocobalamin (RxCUI 309594)
- Recall number
- D-0792-2026
Class II · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
nitroglycerin
- Product
- 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.
- Firm
- American Regent, Inc., Shirley, NY
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lots
- Lot #: 24291, Exp. Date: 8/31/2026
- Quantity
- 98,200 vials
- Distribution
- Nationwide within the U.S
- RxNorm
- nitroglycerin (RxCUI 237205)
- Recall number
- D-0791-2026
Class II · Posted August 26, 2026 · Started July 24, 2026 · Ongoing
acamprosate calcium enteric-coated
- Product
- Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.
- Firm
- Mylan Pharmaceuticals Inc, Morgantown, WV
- Reason
- Failed Dissolution Specifications
- Lots
- Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
- Distribution
- US Nationwide.
- RxNorm
- acamprosate calcium enteric-coated (RxCUI 835726)
- Recall number
- D-0774-2026