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FDA drug recalls

Drug recalls from FDA, newest first. 358 recalls Each recall is dated by the day its recall page names (how recalls are dated).
Agency
Risk level
Status
Date
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1 recall that day

GenTeal Tears and Systane Lubricant Eye Gel

Systane and GenTeal lubricant eye gels may lack sterility, which can impact product quality.

Moderate risk, FDA, Sterility problem

2 recalls that day

Heritage Animal Nutrition Medicated Feed

Heritage Animal Nutrition Medicated Feed may contain rumensin contamination.

High risk, FDA, Ended, Chemical contamination

B. Braun Sterile Water, Dextrose, Sodium Chloride and Lactated Ringer's Injections and Irrigation

B Braun Medical products lack assurance of sterility.

Moderate risk, FDA, Sterility problem

1 recall that day

Leading Pharma Furosemide Tablets

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

Moderate risk, FDA, Drug impurity

1 recall that day

Premier Monsel's Ferric Subsulfate Solution

Monsel's Ferric Subsulfate Solution has an incorrect expiration date printed on the vial.

Low risk, FDA, Labeling error

3 recalls that day

Major Pharmaceuticals Omega-3-Acid Ethyl Esters Capsules

The capsules failed capsule specifications for loss on drying of capsule shells.

Moderate risk, FDA, Quality testing problem

Teva Claravis Isotretinoin Capsules

Teva Pharmaceuticals Claravis (isotretinoin capsule, USP), 10 mg may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

Camber Pantoprazole Sodium Delayed-Release Tablets

Pantoprazole Sodium tablets have discolored spots.

Moderate risk, FDA, Quality problem

3 recalls that day

Skin Script Blemish Spot Treatment

The product failed stability specifications.

Moderate risk, FDA, Quality testing problem

Apotex Desmopressin Nasal Spray

Desmopressin Nasal Spray has defective bottle caps with dislodged or missing liners.

Moderate risk, FDA, Packaging defect

Avantor Performance Materials Magnesium Chloride 6-Hydrate Crystal

Magnesium Chloride, 6-Hydrate, Crystal may be weaker than labeled.

Low risk, FDA, Wrong drug strength

4 recalls that day

International Medication Systems Epinephrine Injection

Epinephrine injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Huons Lidocaine, Bupivacaine and Sodium Chloride Injections

Huons Lidocaine, Bupivacaine and Sodium Chloride Injections lack assurance of sterility.

Moderate risk, FDA, Sterility problem

CoValence Laboratories Hydrocortisone Gels and Balm

Island Kinetics, Inc. d.b.a. CoValence Laboratories is recalling its Remedy Gel, Essential Calming Skin Gel, and Skin Rehab because of Subpotent Drug.

Low risk, FDA, Ended, Wrong drug strength

Nephron SC Albuterol Sulfate Inhalation Solution

Albuterol Sulfate Inhalation Solution has an illegible label.

Moderate risk, FDA, Labeling error

3 recalls that day

Actavis Clonidine Transdermal System

Clonidine Transdermal System, USP, is made with an unapproved raw material.

Moderate risk, FDA, Manufacturing problem

Taro Fluocinonide Cream

The cream failed viscosity specifications.

Moderate risk, FDA, Quality testing problem

Northwest Compounders Semaglutide-Glycine-Cyanocobalamin Injectable

Semaglutide-Glycine-Cyanocobalamin Injectable lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

4 recalls that day

Major Pharmaceuticals Memantine Hydrochloride Extended-Release Capsules

Major Pharmaceuticals Memantine Hydrochloride Extended-Release Capsules may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Owen Biosciences Benzoyl Peroxide Acne Treatments

Owen Biosciences Benzoyl Peroxide Acne Treatments contain benzene, a chemical contamination.

Moderate risk, FDA, Chemical contamination

Cipla Cinacalcet Hydrochloride Tablets

Cinacalcet Hydrochloride Tablets contain N-Nitroso Cinacalcet above the acceptable daily intake limit.

Moderate risk, FDA, Drug impurity

Xiamen Kang Zhongyuan Biotechnology Cough Drops and Throat Soothing Drops

Xiamen Kang Zhongyuan Biotechnology is recalling 15 products.

Moderate risk, FDA, Manufacturing problem

2 recalls that day

GE Healthcare Omnipaque (Iohexol) Injection

Omnipaque (iohexol) Injection contains particulate matter.

Moderate risk, FDA, Foreign object

Huvepharma Amprol 25% Type A Medicated Article

Amprol 25% (amprolium) Type A medicated article is missing its lot number and expiration date on one bag.

Low risk, FDA, Labeling error

3 recalls that day

Blaine Labs Wound Care Gels and Antifungal Creams and Solutions

Blaine Labs Wound Care Gels and Antifungal Creams and Solutions have manufacturing deviations or bacterial contamination.

High risk, FDA, Contamination

Viatris Xanax XR Extended-Release Tablets

Xanax XR, alprazolam, extended-release tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Teva Isotretinoin Capsules

Isotretinoin Capsules 30 mg and 40 mg may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

2 recalls that day

Fagron Compounding Services Norepinephrine and Vancomycin Injections

These injectable drugs lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Preferred Pharmaceuticals Artificial Tears Lubricant Eye Drops

Artificial Tears Lubricant Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

2 recalls that day

Fresenius Kabi Sodium Chloride and Dextrose Injections

Fresenius Kabi Sodium Chloride and Dextrose Injections lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Cipla Lanreotide Injection

Lanreotide Injection lacks assurance of sterility due to deficiencies in visual inspection procedure.

Moderate risk, FDA, Sterility problem

3 recalls that day

Biocon Prazosin Hydrochloride Capsules

Prazosin Hydrochloride Capsules contain a nitrosamine impurity above acceptable limits.

Moderate risk, FDA, Drug impurity

K.C. Pharmaceuticals Eye Drops

K.C. Pharmaceuticals Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Alembic Pharmaceuticals Bromfenac Ophthalmic Solution 0.07%

Bromfenac Ophthalmic Solution 0.07% may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

2 recalls that day

Kian Pee Wan Capsules

The product contains undeclared drug ingredients dexamethasone and cyproheptadine.

High risk, FDA, Hidden drug ingredient

Amneal Tramadol Hydrochloride Tablets

TraMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

1 recall that day

Chiesi Curosurf Intratracheal Suspension

Curosurf (poractant alfa) intratracheal suspension lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

1 recall that day

American Health Packaging Meclizine Hydrochloride Tablets

Meclizine Hydrochloride Tablets failed tablet specifications.

Moderate risk, FDA, Quality testing problem

3 recalls that day

Amneal Pharmaceuticals Magnesium Sulfate in Water for Injection

Magnesium Sulfate in Water for Injection IV bags may contain Tranexamic Acid instead, which can cause adverse events.

High risk, FDA, Labeling error

Teva Octreotide Acetate for Injectable Suspension

Octreotide Acetate for Injectable Suspension lacks assurance of sterility due to quality system deficiencies at the contract manufacturer.

Moderate risk, FDA, Sterility problem

MacLeods Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets USP 150 mcg may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

1 recall that day

International Isotopes Gelatin Capsule Pack for Sodium Iodide I-131 Kit

The Gelatin Capsule Pack for the Sodium Iodide I-131 Kit failed capsule specifications.

Low risk, FDA, Quality testing problem

2 recalls that day

Somerset Therapeutics Dexamethasone Sodium Phosphate Injection

The injection failed impurity specifications during stability testing at expiry.

Moderate risk, FDA, Drug impurity

Norbrook Noromycin 300 LA Oxytetracycline Injection

Noromycin 300 LA antibiotic lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

4 recalls that day

Apotex Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Taro Children's Ibuprofen Oral Suspension

Children's Ibuprofen Oral Suspension contains a gel-like mass and black particles.

Moderate risk, FDA, Foreign object

Cardinal Health Webcol Alcohol Prep Pads

Webcol Alcohol Prep pads may be non-sterile due to microbial contamination, posing an infection risk to vulnerable groups.

High risk, FDA, Sterility problem

Northstar Rx Pitavastatin Tablets

Pitavastatin Tablets, 2 mg contain a foreign tablet of 1 mg Pitavastatin.

Low risk, FDA, Foreign object

1 recall that day

Winder Laboratories Multivitamin with Fluoride Chewable Tablets

Multivitamin with Fluoride Chewable Tablets Grape Flavor may be weaker than labeled.

Low risk, FDA, Wrong drug strength

1 recall that day

Zydus Pharmaceuticals Icosapent Ethyl Capsules

Icosapent Ethyl Capsules have red dots inside and melted capsules due to oxidized active ingredient.

Moderate risk, FDA, Quality testing problem