Arzneimittel & Medikamente Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Showing 24 of 649 results
Pharmaceutical
FDA Drugs
FDA DrugsPapaverine 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.
American Regent, Inc.
FDA DrugsClass I
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.
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
PharmaceuticalFDA Drugs
FDA DrugsCarbamazepine 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.
SUN PHARMACEUTICAL INDUSTRIES INC
FDA DrugsClass II
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.
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Aug 26, 2026SUN PHARMACEUTICAL INDUSTRIES INC
PharmaceuticalFDA Drugs
FDA DrugsACETYLCYSTEINE 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.
American Regent, Inc.
FDA DrugsClass II
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.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
PharmaceuticalFDA Drugs
FDA DrugsTralement (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.
American Regent, Inc.
FDA DrugsClass II
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.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
PharmaceuticalFDA Drugs
FDA DrugsniCARdipine 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.
American Regent, Inc.
FDA DrugsClass II
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.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
PharmaceuticalFDA Drugs
FDA DrugsAcamprosate 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.
Mylan Pharmaceuticals Inc
FDA DrugsClass II
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.
Failed Dissolution Specifications
Aug 26, 2026Mylan Pharmaceuticals Inc
PharmaceuticalFDA Drugs
FDA DrugsAMINAOCAPROIC 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.
American Regent, Inc.
FDA DrugsClass II
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.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
PharmaceuticalFDA Drugs
FDA DrugsSelenious 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.
American Regent, Inc.
FDA DrugsClass II
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.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
PharmaceuticalFDA Drugs
FDA DrugsLibtayo (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
Regeneron Pharmaceuticals Inc
FDA DrugsClass II
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
Lack of Assurance of Sterility
Aug 26, 2026Regeneron Pharmaceuticals Inc
PharmaceuticalFDA Drugs
FDA DrugsPEMRYDI 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
Shilpa Medicare Limited
FDA DrugsClass II
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
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Aug 26, 2026Shilpa Medicare Limited
PharmaceuticalFDA Drugs
FDA DrugsMultrys (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.
American Regent, Inc.
FDA DrugsClass II
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.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
PharmaceuticalFDA Drugs
FDA DrugsACETYLCYSTEINE 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.
American Regent, Inc.
FDA DrugsClass II
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.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
PharmaceuticalFDA Drugs
FDA DrugsNitroglycerin 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.
American Regent, Inc.
FDA DrugsClass II
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.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
PharmaceuticalFDA Drugs
FDA DrugsPEMRYDI 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
Shilpa Medicare Limited
FDA DrugsClass II
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
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Aug 26, 2026Shilpa Medicare Limited
Pharmaceutical
UK
UKMHRA Safety Roundup: August 2026
MHRA
uk-mhraMedicines Recall
MHRA Safety Roundup: August 2026
Summary of the latest safety advice for medicines and medical device users...
Aug 25, 2026MHRA
Pharmaceutical
Australia
AustraliaCAROTONE skin-brightening products found to contain undeclared prescription-only medicine
TGA
au-tgaMedicines Safet...
CAROTONE skin-brightening products found to contain undeclared prescription-only medicine
We are advising consumers that CAROTONE products marketed for skin brightening may pose a serious risk to your health and should not be used....
Aug 24, 2026TGA
PharmaceuticalUK
UKClass 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Zentiva Pharma UK Limited
uk-mhraMedicines Recall
Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles....
Aug 20, 2026Zentiva Pharma UK Limited
PharmaceuticalFDA Drugs
FDA DrugsSEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03
Apollo Care, LLC
FDA DrugsClass II
SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Aug 19, 2026Apollo Care, LLC
PharmaceuticalFDA Drugs
FDA DrugsDiovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
Novartis Pharmaceuticals Corporation
FDA DrugsClass II
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
Failed Dissolution Specifications
Aug 19, 2026Novartis Pharmaceuticals Corporation
PharmaceuticalFDA Drugs
FDA DrugsSILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.
Shoolin Pharma Chem LLP
FDA DrugsClass II
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.
CGMP Deviations:Noted during FDA inspection
Aug 19, 2026Shoolin Pharma Chem LLP
PharmaceuticalFDA Drugs
FDA DrugsTADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08
Shoolin Pharma Chem LLP
FDA DrugsClass II
TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08
CGMP Deviations:Noted during FDA inspection
Aug 19, 2026Shoolin Pharma Chem LLP
PharmaceuticalFDA Drugs
FDA DrugsSEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03
Apollo Care, LLC
FDA DrugsClass II
SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Aug 19, 2026Apollo Care, LLC
PharmaceuticalFDA Drugs
FDA DrugsCefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.
Baxter Healthcare Corporation
FDA DrugsNot Yet Classified
Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.
Presence of Particulate Matter
Aug 19, 2026Baxter Healthcare Corporation
PharmaceuticalFDA Drugs
FDA DrugsTADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.
Shoolin Pharma Chem LLP
FDA DrugsClass II
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.
CGMP Deviations:Noted during FDA inspection
Aug 19, 2026Shoolin Pharma Chem LLP