Drug Recalls

2,051 drug recalls from federal enforcement feeds.

Showing 451–500 of 2,051

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 9, 2026

  Zydus Pharmaceuticals (USA) Inc

  Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC:

  Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

  Class II

• Drug Recall · March 6, 2026

  PAYLESS COMPOUNDERS, LLC

  Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 5, 2026

  Apotex Corp.

  Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 3, 2026

  K.C. Pharmaceuticals, Inc

  Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoD

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 3, 2026

  K.C. Pharmaceuticals, Inc

  Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., Lakewood, NJ 08701

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 3, 2026

  Owen Biosciences Inc.

  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 McKinn

  Chemical contamination: Presence of benzene

  Class II

• Drug Recall · March 3, 2026

  Rising Pharma Holding, Inc.

  Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.

  Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

  Class II

• Drug Recall · March 3, 2026

  Owen Biosciences Inc.

  SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.

  Chemical contamination: Presence of benzene

  Class II

• Drug Recall · March 3, 2026

  K.C. Pharmaceuticals, Inc

  Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 7000

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 3, 2026

  K.C. Pharmaceuticals, Inc

  Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 3, 2026

  Owen Biosciences Inc.

  SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.

  Chemical contamination: Presence of benzene

  Class II

• Drug Recall · March 3, 2026

  K.C. Pharmaceuticals, Inc

  Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC 130209; b) Good

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 3, 2026

  K.C. Pharmaceuticals, Inc

  EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) Walgreens, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 3, 2026

  K.C. Pharmaceuticals, Inc

  Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 3, 2026

  K.C. Pharmaceuticals, Inc

  STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livoni

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 3, 2026

  Owen Biosciences Inc.

  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

  Class II

• Drug Recall · March 2, 2026

  Cardinal Health 200, LLC

  Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.

  Non-Sterility: microbial contamination identified as Paenibacillus phoenicis

  Class I

• Drug Recall · March 2, 2026

  STRIDES PHARMA INC

  Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.

  Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.

  Class II

• Drug Recall · February 26, 2026

  New Life Pharma LLC

  Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06

  Lack of Assurance of Sterility

  Class II

• Drug Recall · February 26, 2026

  New Life Pharma LLC

  Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.

  Lack of Assurance of Sterility

  Class II

• Drug Recall · February 26, 2026

  MACLEODS PHARMA USA, INC

  Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Gua

  Subpotent Drug

  Class II

• Drug Recall · February 26, 2026

  New Life Pharma LLC

  Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.

  Lack of Assurance of Sterility

  Class II

• Drug Recall · February 26, 2026

  New Life Pharma LLC

  Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.

  Lack of Assurance of Sterility

  Class II

• Drug Recall · February 24, 2026

  MYLAN PHARMACEUTICALS INC

  Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-66

  Failed Dissolution Specifications

  Class II

• Drug Recall · February 19, 2026

  Radnostix

  Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 692

  Failed Tablet/Capsule Specifications

  Class III

• Drug Recall · February 18, 2026

  Cipla USA, Inc.

  Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, N

  Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

  Class III

• Drug Recall · February 18, 2026

  HTO Nevada Inc. dba Kirkman

  MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

  Stability Data Does Not Support Expiry Date.

  Class II

• Drug Recall · February 18, 2026

  HTO Nevada Inc. dba Kirkman

  FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.

  Stability Data Does Not Support Expiry Date.

  Class II

• Drug Recall · February 18, 2026

  HTO Nevada Inc. dba Kirkman

  MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.

  Stability Data Does Not Support Expiry Date.

  Class II

• Drug Recall · February 18, 2026

  Cipla USA, Inc.

  Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individua

  Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

  Class III

• Drug Recall · February 17, 2026

  The Harvard Drug Group LLC

  Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.

  Defective container; inadequately sealed blister packaging.

  Class II

• Drug Recall · February 13, 2026

  AvKARE

  Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.

  Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.

  Class II

• Drug Recall · February 13, 2026

  Harbin Jixianglong Biotech Co., Ltd.

  Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 8438

  CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

  Class II

• Drug Recall · February 13, 2026

  Harbin Jixianglong Biotech Co., Ltd.

  Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbi

  CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

  Class II

• Drug Recall · February 12, 2026

  Slate Run Pharmaceuticals

  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 Econ

  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.

  Class III

• Drug Recall · February 10, 2026

  LEO PHARMA INC

  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, Manu

  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.

  Class II

• Drug Recall · February 9, 2026

  Meitheal Pharmaceuticals, Inc

  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

  Class II

• Drug Recall · February 5, 2026

  Fresenius Kabi Compounding, LLC

  vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.

  Lack of Assurance of Sterility

  Class II

• Drug Recall · February 5, 2026

  Fresenius Kabi Compounding, LLC

  ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56

  Lack of Assurance of Sterility

  Class II

• Drug Recall · February 5, 2026

  Fresenius Kabi Compounding, LLC

  vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59

  Lack of Assurance of Sterility

  Class II

• Drug Recall · February 5, 2026

  Fresenius Kabi Compounding, LLC

  thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.

  Lack of Assurance of Sterility

  Class II

• Drug Recall · February 5, 2026

  Fresenius Kabi Compounding, LLC

  acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56

  Lack of Assurance of Sterility

  Class II

• Drug Recall · February 4, 2026

  SOMERSET THERAPEUTICS LLC

  Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-02

  Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.

  Class II

• Drug Recall · February 3, 2026

  Annora Pharma Private Limited

  Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, Indi

  Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg

  Class III

• Drug Recall · February 2, 2026

  Pro Numb Tattoo Numbing Spray LLC

  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

  Class II

• Drug Recall · February 2, 2026

  Pro Numb Tattoo Numbing Spray LLC

  Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11

  cGMP deviations

  Class II

• Drug Recall · January 29, 2026

  Teva Pharmaceuticals USA, Inc

  Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

  Failed Dissolution Specifications

  Class II

• Drug Recall · January 29, 2026

  Teva Pharmaceuticals USA, Inc

  Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

  Failed Dissolution Specifications

  Class II

• Drug Recall · January 29, 2026

  Teva Pharmaceuticals USA, Inc

  Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.

  Failed Dissolution Specifications

  Class II