Drug Recalls

1,822 drug recalls from federal enforcement feeds.

Showing 201–250 of 1,822

• Drug Recall · March 17, 2026

  Chiesi USA, Inc.

  CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 16, 2026

  Cipla USA, Inc.

  Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300,

  CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

  Class II

• Drug Recall · March 16, 2026

  Cipla USA, Inc.

  Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300,

  CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

  Class II

• Drug Recall · March 16, 2026

  Cipla USA, Inc.

  Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300,

  CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

  Class II

• Drug Recall · March 16, 2026

  Amerisource Health Services LLC

  Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus,

  Failed tablet specifications.

  Class II

• Drug Recall · March 13, 2026

  Cipla USA, Inc.

  Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured f

  Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

  Class II

• Drug Recall · March 13, 2026

  Cipla USA, Inc.

  Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc.,

  Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

  Class II

• Drug Recall · March 13, 2026

  ENDO USA, Inc.

  Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

  Crystallization; identified as Buprenorphine free base

  Class II

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-

  Lack of Assurance of Sterility

  Class II

• 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 11, 2026

  Fresenius Kabi USA, LLC

  0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distribut

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use N

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical C

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Dist

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-4

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distribu

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use ND

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 6

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 6

  Lack of Assurance of Sterility

  Class II

• Drug Recall · March 11, 2026

  Fresenius Kabi USA, LLC

  0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of U

  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 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.

  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

  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

  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

  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

  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

  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 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

  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

  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 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, 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 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

  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

  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 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

  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 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