Arzneimittel & Medikamente Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Showing 24 of 649 results
Pharmaceutical
FDA Drugs
FDA DrugsDEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
B BRAUN MEDICAL INC
FDA DrugsClass II
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Apr 29, 2026B BRAUN MEDICAL INC
PharmaceuticalFDA Drugs
FDA DrugsPremier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.
Premier Dental Products Co
FDA DrugsClass III
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Apr 29, 2026Premier Dental Products Co
Pharmaceutical
UK
UKMHRA Safety Roundup: April 2026
MHRA
uk-mhraMedicines Recall
MHRA Safety Roundup: April 2026
Summary of the latest safety advice for medicines and medical device users...
Apr 29, 2026MHRA
PharmaceuticalFDA Drugs
FDA DrugsFurosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Leading Pharma, LLC
FDA DrugsClass II
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Apr 29, 2026Leading Pharma, LLC
PharmaceuticalFDA Drugs
FDA DrugsLACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
B BRAUN MEDICAL INC
FDA DrugsClass II
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Apr 29, 2026B BRAUN MEDICAL INC
PharmaceuticalFDA Drugs
FDA DrugsFRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Harrow Eye LLC
FDA DrugsClass II
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Lack of Assurance of Sterility
Apr 29, 2026Harrow Eye LLC
PharmaceuticalFDA Drugs
FDA DrugsOmega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
The Harvard Drug Group LLC
FDA DrugsClass II
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Apr 29, 2026The Harvard Drug Group LLC
PharmaceuticalFDA Drugs
FDA Drugs0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
B BRAUN MEDICAL INC
FDA DrugsClass II
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Apr 29, 2026B BRAUN MEDICAL INC
PharmaceuticalFDA Drugs
FDA DrugsClaravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Teva Pharmaceuticals USA, Inc
FDA DrugsClass II
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Apr 29, 2026Teva Pharmaceuticals USA, Inc
PharmaceuticalFDA Drugs
FDA DrugsPantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10
Hetero Labs Limited (Unit V)
FDA DrugsClass II
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Apr 29, 2026Hetero Labs Limited (Unit V)
PharmaceuticalFDA Drugs
FDA DrugsSterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
B BRAUN MEDICAL INC
FDA DrugsClass II
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Apr 29, 2026B BRAUN MEDICAL INC
PharmaceuticalUK
UKClass 2 Medicines Recall: Amarox Limited, Sertraline 100mg film-coated tablets, EL(26)A/22
Amarox Limited
uk-mhraMedicines Recall
Class 2 Medicines Recall: Amarox Limited, Sertraline 100mg film-coated tablets, EL(26)A/22
Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site....
Apr 28, 2026Amarox Limited
Pharmaceutical
Australia
AustraliaExtension of substitution approval for shortage of Catapres (clonidine) 150 mcg tablets
TGA
au-tgaMedicines Safet...
Extension of substitution approval for shortage of Catapres (clonidine) 150 mcg tablets
Serious Scarcity Substitution Instrument (SSSI) has lapsed and product is available....
Apr 27, 2026TGA
PharmaceuticalUK
UKClass 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21
Omega Pharma Ltd
uk-mhraMedicines Recall
Class 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21
Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the Patient Information Leaflet (PIL) and on the Carton in ...
Apr 24, 2026Omega Pharma Ltd
PharmaceuticalFDA Drugs
FDA DrugsSkin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
Island Kinetics, Inc. d.b.a. CoValence Laboratories
FDA DrugsClass III
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
Subpotent Drug
Apr 22, 2026Island Kinetics, Inc. d.b.a. CoValence Laboratories
PharmaceuticalFDA Drugs
FDA DrugsMemantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
The Harvard Drug Group LLC
FDA DrugsClass II
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
Failed Dissolution Specifications
Apr 22, 2026The Harvard Drug Group LLC
PharmaceuticalFDA Drugs
FDA DrugsBlemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Island Kinetics, Inc. d.b.a. CoValence Laboratories
FDA DrugsClass II
Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Failed Stability Specifications
Apr 22, 2026Island Kinetics, Inc. d.b.a. CoValence Laboratories
PharmaceuticalFDA Drugs
FDA DrugsHydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027
Owen Biosciences Inc.
FDA DrugsClass II
HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027
Chemical contamination: Presence of benzene
Apr 22, 2026Owen Biosciences Inc.
PharmaceuticalFDA Drugs
FDA DrugsLidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)
Huons Co., Ltd.
FDA DrugsClass II
Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)
Lack of Assurance of Sterility
Apr 22, 2026Huons Co., Ltd.
PharmaceuticalFDA Drugs
FDA DrugsFluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.
SUN PHARMACEUTICAL INDUSTRIES INC
FDA DrugsClass II
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Apr 22, 2026SUN PHARMACEUTICAL INDUSTRIES INC
PharmaceuticalFDA Drugs
FDA DrugsEPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
International Medication Systems Ltd.
FDA DrugsClass II
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
Lack of Assurance of Sterility
Apr 22, 2026International Medication Systems Ltd.
PharmaceuticalUK
UKClass 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20
Doncaster Pharma Limited
uk-mhraMedicines Recall
Class 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20
Doncaster Pharma Limited has informed the MHRA of an error related to the Braille embossing on the outer packaging of certain parallel imported batches of Hiprex 1 g tablets (POM)....
Apr 22, 2026Doncaster Pharma Limited
PharmaceuticalFDA Drugs
FDA DrugsAlbuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
Nephron SC, LLC
FDA DrugsClass II
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
Labelling: Illegible label
Apr 22, 2026Nephron SC, LLC
PharmaceuticalFDA Drugs
FDA DrugsFHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas
Owen Biosciences Inc.
FDA DrugsClass II
FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas
Chemical contamination: Presence of benzene
Apr 22, 2026Owen Biosciences Inc.