Arzneimittel & Medikamente Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Showing 24 of 649 results
Pharmaceutical
FDA Drugs
FDA DrugsVista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
PharmaceuticalFDA Drugs
FDA DrugsAdbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,
LEO PHARMA INC
FDA DrugsClass II
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Mar 4, 2026LEO PHARMA INC
PharmaceuticalFDA Drugs
FDA DrugsBio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
PharmaceuticalFDA Drugs
FDA DrugsCHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Wizcure Pharmaa Private Limited
FDA DrugsClass II
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
PharmaceuticalFDA Drugs
FDA DrugsVista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
PharmaceuticalFDA Drugs
FDA DrugsEptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Slate Run Pharmaceuticals
FDA DrugsClass III
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Mar 4, 2026Slate Run Pharmaceuticals
PharmaceuticalFDA Drugs
FDA DrugsVista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
PharmaceuticalFDA Drugs
FDA DrugsAgebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
Agebox
FDA DrugsClass II
Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Mar 4, 2026Agebox
PharmaceuticalFDA Drugs
FDA DrugsVista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
PharmaceuticalFDA Drugs
FDA DrugsBioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
Pharmaceutical
Australia
AustraliaShortage of Zimstat (simvastatin) 5 mg tablets and substitution approval extended
TGA
au-tgaMedicines Safet...
Shortage of Zimstat (simvastatin) 5 mg tablets and substitution approval extended
We have extended the SSSI in response to the ongoing shortage...
Feb 26, 2026TGA
Pharmaceutical
UK
UKMHRA Safety Roundup: February 2026
MHRA
uk-mhraMedicines Recall
MHRA Safety Roundup: February 2026
Summary of the latest safety advice for medicines and medical device users...
Feb 25, 2026MHRA
PharmaceuticalUK
UKClass 4 Medicines Defect Notification: Rayner Pharmaceuticals Limited, Dropodex 0.1% w/v Eye Drops, solution, EL(26)A/10
Rayner Pharmaceuticals Limited
uk-mhraMedicines Recall
Class 4 Medicines Defect Notification: Rayner Pharmaceuticals Limited, Dropodex 0.1% w/v Eye Drops, solution, EL(26)A/10
Rayner Pharmaceuticals limited have informed the MHRA that the batches listed in this notification do not include the concentration of phosphates in the product information....
Feb 24, 2026Rayner Pharmaceuticals Limited
PharmaceuticalUK
UKClass 2 Medicines Recall: Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515), KidNaps (Melatonin) 1mg in 1ml Oral Solution, EL(26)A/09
Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515)
uk-mhraMedicines Recall
Class 2 Medicines Recall: Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515), KidNaps (Melatonin) 1mg in 1ml Oral Solution, EL(26)A/09
Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are recalling all batches of KidNaps (Melatonin) 1mg in 1ml Oral Solution due to out of specification stability results....
Feb 23, 2026Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515)
PharmaceuticalFDA Drugs
FDA DrugsESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalFDA Drugs
FDA DrugsCetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.
Meitheal Pharmaceuticals, Inc
FDA DrugsClass II
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.
Defective Delivery System: Missing or duplicated needles within the injection kit
Feb 18, 2026Meitheal Pharmaceuticals, Inc
PharmaceuticalFDA Drugs
FDA DrugsPro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11
Pro Numb Tattoo Numbing Spray LLC
FDA DrugsClass II
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11
cGMP deviations
Feb 18, 2026Pro Numb Tattoo Numbing Spray LLC
PharmaceuticalFDA Drugs
FDA DrugsTestosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalFDA Drugs
FDA DrugsESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalFDA Drugs
FDA DrugsTestosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalFDA Drugs
FDA DrugsTestosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalFDA Drugs
FDA DrugsESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalFDA Drugs
FDA DrugsESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalFDA Drugs
FDA DrugsESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
Presence of Foreign substance - potential presence of metal particulate matter
Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)