Drug Recalls

1,842 drug recalls from federal enforcement feeds.

Showing 1,301–1,350 of 1,842

• Drug Recall · October 11, 2024

  Padagis US LLC

  Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05

  Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

  Class III

• Drug Recall · October 10, 2024

  ACCORD HEALTHCARE, INC.

  Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured b

  CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

  Class II

• Drug Recall · October 10, 2024

  Breckenridge Pharmaceutical, Inc

  Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.

  CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

  Class II

• Drug Recall · October 10, 2024

  ACCORD HEALTHCARE, INC.

  Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured

  CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

  Class II

• Drug Recall · October 10, 2024

  ACCORD HEALTHCARE, INC.

  Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured

  CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

  Class II

• Drug Recall · October 9, 2024

  Dr. Reddy's Laboratories, Inc.

  Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.

  CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

  Class II

• Drug Recall · October 9, 2024

  Dr. Reddy's Laboratories, Inc.

  Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

  CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

  Class II

• Drug Recall · October 9, 2024

  Dr. Reddy's Laboratories, Inc.

  Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

  CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

  Class II

• Drug Recall · October 8, 2024

  C & A Naturistics

  AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,

  Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.

  Class II

• Drug Recall · October 8, 2024

  Neogen Corporation

  LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01

  CGMP violations.

  Class II

• Drug Recall · October 8, 2024

  Neogen Corporation

  LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02

  CGMP violations.

  Class II

• Drug Recall · October 1, 2024

  ACCORD HEALTHCARE, INC.

  Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals L

  Failed Impurities/Degradation Specifications.

  Class II

• Drug Recall · September 30, 2024

  Staska Pharmaceuticals, Inc.

  Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317

  Presence of Particulate Matter: Presence of glass particulates.

  Class I

• Drug Recall · September 30, 2024

  Glenmark Pharmaceuticals Inc., USA

  Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: G

  Defective Container: Firm received complaints of broken tube at the seal.

  Class III

• Drug Recall · September 25, 2024

  Fresenius Kabi Compounding, LLC

  Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58

  cGMP violations

  Class II

• Drug Recall · September 25, 2024

  Fresenius Kabi Compounding, LLC

  Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

  cGMP violations

  Class II

• Drug Recall · September 25, 2024

  Fresenius Kabi Compounding, LLC

  EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

  cGMP violations

  Class II

• Drug Recall · September 25, 2024

  Fresenius Kabi Compounding, LLC

  NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58

  cGMP violations

  Class II

• Drug Recall · September 25, 2024

  Denison Pharmaceuticals, LLC

  Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-696

  Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

  Class III

• Drug Recall · September 25, 2024

  Fresenius Kabi Compounding, LLC

  Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

  cGMP violations

  Class II

• Drug Recall · September 25, 2024

  Fresenius Kabi Compounding, LLC

  Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58

  CGMP violations

  Class II

• Drug Recall · September 25, 2024

  Denison Pharmaceuticals, LLC

  Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-696

  Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

  Class III

• Drug Recall · September 25, 2024

  Fresenius Kabi Compounding, LLC

  Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58

  cGMP violations

  Class II

• Drug Recall · September 25, 2024

  Fresenius Kabi Compounding, LLC

  Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

  cGMP violations

  Class II

• Drug Recall · September 25, 2024

  Fresenius Kabi Compounding, LLC

  Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58

  cGMP violations

  Class II

• Drug Recall · September 25, 2024

  Fresenius Kabi Compounding, LLC

  NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58

  cGMP violations

  Class II

• Drug Recall · September 24, 2024

  VIONA PHARMACEUTICALS INC

  Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.

  Crystallization

  Class II

• Drug Recall · September 24, 2024

  Nivagen Pharmaceuticals Inc

  Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Va

  Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

  Class II

• Drug Recall · September 24, 2024

  Glenmark Pharmaceuticals Inc., USA

  Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43

  Defective Delivery System: The dip tube is clogged causing the spray not to work.

  Class II

• Drug Recall · September 23, 2024

  Advanced Accelerator Applications USA, Inc.

  Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millbur

  CGMP deviations

  Class II

• Drug Recall · September 19, 2024

  Gilead Sciences, Inc.

  Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2

  Presence of Particulate Matter: Presence of glass particle.

  Class I

• Drug Recall · September 18, 2024

  EnviroServe Chemicals Inc.

  EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1

  CGMP deviations

  Class II

• Drug Recall · September 18, 2024

  123Herbals

  Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.

  Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.

  Class I

• Drug Recall · September 17, 2024

  Bionpharma Inc.

  Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

  Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

  Class I

• Drug Recall · September 16, 2024

  AbbVie Inc.

  Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,

  Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

  Class II

• Drug Recall · September 16, 2024

  AbbVie Inc.

  Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 3002303

  Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

  Class II

• Drug Recall · September 11, 2024

  Mckesson Medical-Surgical Inc. Corporate Office

  Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Di

  cGMP Deviations: Temperature excursion

  Class II

• Drug Recall · September 11, 2024

  Zhejiang Jingwei Pharmaceutical Co., Ltd.

  First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made

  Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.

  Class II

• Drug Recall · September 11, 2024

  Mckesson Medical-Surgical Inc. Corporate Office

  Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06

  Temperature abuse: Products exposed to improper temperature above drug label specifications.

  Class II

• Drug Recall · September 5, 2024

  Empower Pharmacy

  Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041

  Lack of Assurance of Sterility

  Class II

• Drug Recall · September 3, 2024

  Vivier Pharma, Inc.

  Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Cha

  Microbial Contamination of Non-Sterile Product

  Class II

• Drug Recall · September 3, 2024

  Ascend Laboratories, LLC

  Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, N

  Failed Dissolution Specifications

  Class II

• Drug Recall · August 30, 2024

  Glenmark Pharmaceuticals Inc., USA

  Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430,

  Subpotent Drug

  Class II

• Drug Recall · August 28, 2024

  PREQUEL SKIN

  BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4

  Microbial contamination of non-sterile Products -

  Class II

• Drug Recall · August 24, 2024

  Rubicon Research Private Limited

  AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01

  Discoloration

  Class III

• Drug Recall · August 22, 2024

  ProRx LLC

  Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 22, 2024

  ProRx LLC

  SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 22, 2024

  ProRx LLC

  TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 22, 2024

  ProRx LLC

  SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 22, 2024

  ProRx LLC

  TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01

  Lack of Assurance of Sterility

  Class II