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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).
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1 recall that day

Fresenius Kabi Epinephrine Injection

Fresenius Kabi Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial may contain more impurities than allowed.

Low risk, FDA, Drug impurity

1 recall that day

Gas-X Extra Strength Softgels

Gas-X Extra Strength Softgels may be contaminated with a diluted propylene glycol-based coolant, which could cause nausea, vomiting, abdominal pain.

High risk, FDA, Chemical contamination

4 recalls that day

Lannett Niacin Extended-Release Tablets

Lannett Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Guardian Drug Antacid Tablets

Guardian Drug Antacid Tablets contain small metallic particles.

Moderate risk, FDA, Foreign object

Forte BioPharma Xyvona (Levorphanol Tartrate Tablets)

Forte BioPharma Xyvona (levorphanol tartrate tablets) has labeling issues.

Moderate risk, FDA, Labeling error

Asclemed USA Duloxetine DR Capsules

Duloxetine DR Capsules contain a nitrosamine impurity above the acceptable intake limit.

Moderate risk, FDA, Drug impurity

2 recalls that day

Spectra Medical Devices Lidocaine HCl Injection

Lidocaine HCl Injection USP lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets

Amlodipine and Olmesartan Medoxomil Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

1 recall that day

Eugia Lidocaine HCl Injection

Lidocaine HCl Injection has a label wrap that covers the barcode, making it hard to scan.

Low risk, FDA, Labeling error

1 recall that day

Better Weather Actives Fix Elixir

Better Weather Fix Elixir may contain undeclared Mitragynine and Mitragynine Pseudoindoxyl, which can cause nausea, vomiting, and rapid heart rate.

Not yet rated, FDA

1 recall that day

AbbVie Pred Mild Ophthalmic Suspension

Pred Mild ophthalmic suspension failed stability specifications.

Low risk, FDA, Quality testing problem

1 recall that day

Aveva Nicotine Transdermal System Patch

Aveva Nicotine Transdermal System Patch may contain more impurities than allowed.

Low risk, FDA, Drug impurity

1 recall that day

Lloyd ToxiBan Charcoal-Kaolin Suspension

Microbial levels in the oral medication exceeded specification limits.

Moderate risk, FDA, Contamination

2 recalls that day

IntegraDose Compounding Services Fentanyl Citrate Injection

FentaNYL Citrate, Sterile CADD for Injection may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Nephronex Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid

The oral liquid supplement contains black particles.

Moderate risk, FDA, Foreign object

3 recalls that day

ANI Pharmaceuticals Estradiol Gel

Estradiol Gel packets may be empty or partially full.

Moderate risk, FDA, Packaging defect

UCB Cimzia Prefilled Syringes

Cimzia prefilled syringes lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Zydus Erythromycin Tablets

Erythromycin Tablets contain N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit.

Moderate risk, FDA, Drug impurity

2 recalls that day

Gas-X Simethicone Antigas Softgels

Gas-X antigas softgels have incomplete inactive ingredient information on the carton labeling.

Moderate risk, FDA, Labeling error

Lupin Pharmaceuticals Liraglutide Injection

Liraglutide Injection contains a white thread-like particulate matter in the cartridge.

Moderate risk, FDA, Foreign object

5 recalls that day

Safecor Health Atomoxetine Capsules

Atomoxetine Capsules HCL, 10 mg Capsules are mislabeled, containing 25 mg instead of 10 mg.

Moderate risk, FDA, Labeling error

American Health Packaging Primidone Tablets

Primidone Tablets are contaminated with trace amounts of Acemetacin API, which can cause cross contamination.

Low risk, FDA, Contamination

Sagent Pharmaceuticals Busulfan Injection

Sagent Pharmaceuticals Busulfan Injection may contain more impurities than allowed.

Low risk, FDA, Drug impurity

Golden State Medical Supply Primidone Tablets

Primidone Tablets are contaminated with trace amounts of Acemetacin.

Low risk, FDA, Contamination

Lannett Primidone Tablets

Primidone Tablets are contaminated with trace amounts of Acemetacin.

Low risk, FDA, Contamination

1 recall that day

Dechra Veterinary Products Ophthavet Ophthalmic Solution for Dogs and Cats

Ophthavet Ophthalmic Solution may lack sterility assurance due to a potential quality concern at the manufacturing site.

Moderate risk, FDA, Sterility problem

1 recall that day

Sun Pharmaceutical Doxorubicin Hydrochloride Liposome Injection

DOXOrubin Hydrochloride Liposome injection contains glass particles that may cause irritation, swelling, blocked blood vessels, or life-threatening clots.

High risk, FDA, Foreign object

3 recalls that day

Erotic Enhancers WAP Sensual Enhancement Capsules

WAP Sensual Enhancement Capsules contain undeclared sildenafil, tadalafil, and flibanserin, which can lower blood pressure dangerously.

High risk, FDA, Hidden drug ingredient

Ascend Laboratories Metoprolol Succinate Extended-Release Tablets

Ascend Laboratories, LLC Metoprolol Succinate Extended-Release Tablets, USP, 25 mg may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Endo USA Buprenorphine Hydrochloride Injection

Buprenorphine Hydrochloride Injection contains particulate matter identified as Buprenorphine free base.

Moderate risk, FDA, Foreign object

2 recalls that day

MG217 Multi-Symptom Treatment Cream & Skin Protectant

MG217 Multi-Symptom Treatment Cream is contaminated with Staphylococcus aureus and could cause infections.

High risk, FDA, Contamination

Oasis Tears PF Preservative-Free Lubricant Eye Drops

Oasis Tears PF lubricant eye drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

1 recall that day

Central Admixture Pharmacy Services TPN Bags

The TPN bag did not contain insulin as listed on the label.

Moderate risk, FDA, Labeling error

2 recalls that day

Breckenridge Pharmaceutical Duloxetine Delayed-Release Capsules

Duloxetine Delayed-Release Capsules contain an impurity above the recommended limit.

Moderate risk, FDA, Drug impurity

Acella Naproxen Oral Suspension

The product is chemically contaminated with lead and lithium above specification.

Moderate risk, FDA, Chemical contamination

4 recalls that day

Covetrus and VetOne Amoxicillin and Clavulanate Potassium Oral Suspension Drops for Dogs and Cats

This voluntary recall is due to market complaints pertaining to product discoloration following reconstitution.

Moderate risk, FDA, Quality problem

Teva Octreotide Acetate for Injectable Suspension

Octreotide Acetate for Injectable Suspension lacks assurance of sterility due to quality system deficiencies.

Moderate risk, FDA, Sterility problem

Rising Pharma Enalapril Maleate Tablets

Enalapril Maleate Tablets, USP, 20 mg may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

BD PurPrep Povidone-Iodine and Isopropyl Alcohol Antiseptic Solution

BD PurPrep sterile solution may lack sterility assurance due to potential contamination.

Moderate risk, FDA, Sterility problem

3 recalls that day

Fresenius Medical Care Delflex Peritoneal Dialysis Solution

Delflex, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set may leak from perforations in bags, lacking assurance of sterility.

Moderate risk, FDA, Sterility problem

Ajanta Pharma Duloxetine Delayed-Release Capsules

Duloxetine Delayed-Release Capsules contain an impurity above the FDA recommended limit.

Moderate risk, FDA, Drug impurity

Harrow Eye FreshKote Lubricant Eye Drops

Freshkote Lubricant Eyedrops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

1 recall that day

Unichem busPIRone Hydrochloride Tablets

BusPIRone Hydrochloride Tablets, USP, 5 mg may be weaker than labeled.

Low risk, FDA, Wrong drug strength

1 recall that day

CVS Pharmacy Lidocaine Wound Gel

Water-Jel Technologies is recalling its Lidocaine Wound Gel because failed PH specifications.

Low risk, FDA, Quality testing problem

1 recall that day

Hikma Pharmaceuticals Alendronate Sodium Oral Solution

Some bottles of Alendronate Sodium Oral Solution have out of specification assay results.

Moderate risk, FDA, Quality testing problem

5 recalls that day

B. Braun Lactated Ringer's Injection

Lactated Ringer's Injection USP contains particulate matter that can cause patient harm if infused.

High risk, FDA, Foreign object

Optase Dry Eye Intense Drops (Glycerin 0.2%)

Optase Dry Eye Intense Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

iVIZIA Sterile Lubricant Eye Drops

The eye drops lack assurance of sterility due to CGMP deviations found during an FDA inspection.

Moderate risk, FDA, Sterility problem

American Regent Levocarnitine Injection

Levocarnitine Injection is missing its label.

Low risk, FDA, Labeling error

Wells Pharma Phenylephrine, Fentanyl and Ketamine Injectable Solutions

Wells Pharma Phenylephrine, Fentanyl and Ketamine Injectable Solutions have cGMP deviations.

Moderate risk, FDA, Manufacturing problem