Drug Recalls

2,051 drug recalls from federal enforcement feeds.

Showing 1–50 of 2,051

• Drug Recall · September 15, 2026

  Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

  Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Product

  Lack of Assurance of Sterility

  Class II

• Drug Recall · September 15, 2026

  Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

  Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarry

  Lack of Assurance of Sterility

  Class II

• Drug Recall · September 14, 2026

  SUN PHARMACEUTICAL INDUSTRIES INC

  Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-1289

  Failed Stability Specifications

  Not Yet Classified

• Drug Recall · September 4, 2026

  Pfizer

  Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.

  Lack of Assurance of Sterility

  Class II

• Drug Recall · September 3, 2026

  Inventia Healthcare Limited

  Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01

  Failed Dissolution Specifications

  Class II

• Drug Recall · September 3, 2026

  OurPharma LLC

  fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.

  Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).

  Class II

• Drug Recall · August 31, 2026

  SUN PHARMA /TARO

  Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC:

  Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

  Class II

• Drug Recall · August 31, 2026

  Supernus Pharmaceuticals, Inc.

  Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc.

  Failed dissolution specifications.

  Class III

• Drug Recall · August 28, 2026

  Amneal Pharmaceuticals of New York, LLC

  Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India;

  Defective Delivery System: Possibility of no medication in the prefilled pen.

  Class II

• Drug Recall · August 27, 2026

  Macleods Pharmaceuticals Limited

  Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA

  Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

  Class III

• Drug Recall · August 26, 2026

  Mylan Pharmaceuticals Inc

  Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-38

  Failed Dissolution Specifications

  Class II

• Drug Recall · August 25, 2026

  Ajanta Pharma USA Inc

  Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.

  Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.

  Class III

• Drug Recall · August 24, 2026

  ImprimisRx NJ LLC

  Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10

  Subpotent Drug

  Class III

• Drug Recall · August 24, 2026

  Teva Pharmaceuticals USA, Inc

  traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC

  Presence of Foreign Tablets/Capsules

  Class II

• Drug Recall · August 24, 2026

  Hikma Pharmaceuticals USA INC.

  Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 334

  Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

  Class II

• Drug Recall · August 21, 2026

  VITRUVIAS THERAPEUTICS INC

  Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by: Vitruvias Therapeutics, Auburn, AL 36830, Pro

  Superpotent Drug

  Class I

• Drug Recall · August 21, 2026

  Golden State Medical Supply Inc.

  Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.

  Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution

  Class II

• Drug Recall · August 21, 2026

  Lexia LLC

  Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003

  CGMP Deviations: Potential contamination of raw material

  Class II

• Drug Recall · August 21, 2026

  Lexia LLC

  Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8

  CGMP Deviations: Potential contamination of raw material

  Class II

• Drug Recall · August 20, 2026

  Sterling Pharmaceutical Services LLC

  TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 20, 2026

  Sterling Pharmaceutical Services LLC

  AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 20, 2026

  Sterling Pharmaceutical Services LLC

  AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 20, 2026

  Sterling Pharmaceutical Services LLC

  Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-07

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 20, 2026

  Sterling Pharmaceutical Services LLC

  Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15.

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 20, 2026

  Sterling Pharmaceutical Services LLC

  Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8833

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 20, 2026

  Sterling Pharmaceutical Services LLC

  Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55.

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 20, 2026

  Sterling Pharmaceutical Services LLC

  Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 20, 2026

  Sterling Pharmaceutical Services LLC

  Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38

  Lack of Assurance of Sterility

  Class II

• Drug Recall · August 19, 2026

  American Health Packaging

  Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-

  Labeling: Label Mix-up

  Class III

• Drug Recall · August 19, 2026

  B BRAUN MEDICAL INC

  0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.

  Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene

  Class I

• Drug Recall · August 19, 2026

  Chiesi USA, Inc.

  Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01

  Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

  Class III

• Drug Recall · August 18, 2026

  Sage Products, LLC

  2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26

  Cross Contamination with Other Products

  Class II

• Drug Recall · August 17, 2026

  Baxter Healthcare Corporation

  Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06

  Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.

  Class I

• Drug Recall · August 17, 2026

  Mylan Pharmaceuticals Inc

  Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.

  Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

  Class II

• Drug Recall · August 17, 2026

  Baxter Healthcare Corporation

  0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03

  Presence of particulate matter: Particulates identified as fiberglass

  Class I

• Drug Recall · August 14, 2026

  Allies Group Inc.

  THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Lt

  Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

  Class II

• Drug Recall · August 14, 2026

  Allies Group Inc.

  THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 06891

  Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

  Class II

• Drug Recall · August 14, 2026

  Allies Group Inc.

  THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.

  Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

  Class II

• Drug Recall · August 14, 2026

  Allies Group Inc.

  THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UP

  Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

  Class II

• Drug Recall · August 13, 2026

  Apotex Corp.

  Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326,

  Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

  Class II

• Drug Recall · August 13, 2026

  Safecor Health, LLC

  Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16

  Failed Stability Specifications

  Class II

• Drug Recall · August 13, 2026

  Safecor Health, LLC

  Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16

  Failed Stability Specifications

  Class II

• Drug Recall · August 13, 2026

  Safecor Health, LLC

  Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

  Failed Stability Specifications

  Class II

• Drug Recall · August 13, 2026

  Safecor Health, LLC

  Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

  Failed Stability Specifications

  Class II

• Drug Recall · August 13, 2026

  Safecor Health, LLC

  Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

  Failed Stability Specifications

  Class II

• Drug Recall · August 13, 2026

  Safecor Health, LLC

  Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

  Failed Stability Specifications

  Class II

• Drug Recall · August 12, 2026

  B BRAUN MEDICAL INC

  Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00

  Presence of Particulate matter.

  Class I

• Drug Recall · August 11, 2026

  American Regent, Inc.

  Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-303

  Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.

  Class I

• Drug Recall · August 10, 2026

  Fresenius Kabi USA, LLC

  Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.

  Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

  Class I

• Drug Recall · August 10, 2026

  Church & Dwight Co., Inc.

  Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 73221

  CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing

  Class II