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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

Huvepharma BioCox 60 Type A Medicated Article

The product failed to meet stability specification requirements for assay at the 6M and 9M timepoints.

Moderate risk, FDA, Quality testing problem

4 recalls that day

Nomida Semaglutide and Tirzepatide Injections

Semaglutide and tirzepatide sterile multi-dose vials lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Radnostix Sodium Iodide I-131 Oral Solution

Sodium Iodide (I-131) Solution contains particulate matter due to production issues.

Moderate risk, FDA, Foreign object

Mohamed Hagar Mojo Max Fusion XXX Capsules

Mojo Max Fusion XXX contains undeclared sildenafil and tadalafil.

High risk, FDA, Hidden drug ingredient

MR. 7 Super 700000 Capsules

The product is marketed without an approved NDA/Anda.

High risk, FDA, Hidden drug ingredient

3 recalls that day

Rising Pharmaceuticals Temozolomide Capsules, 5mg

Rising Pharmaceuticals Temozolomide Capsules, 5mg may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

Dermal Source Five-Star Vasocaine Spray and Maximum Zone Lidocaine Creams

Five-Star Vasocaine Spray and Maximum Zone 1 and Zone 2 Lidocaine Creams have stability data that does not support their expiry dates.

Moderate risk, FDA, Quality testing problem

Mylan Amnesteem Isotretinoin Capsules

Amnesteem (Isotretinoin) Capsules, USP 40 mg may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

2 recalls that day

Cipla Nilotinib Capsules

The capsules failed a test for appearance after six months.

Low risk, FDA, Quality testing problem

Major Pharmaceuticals Midodrine Hydrochloride Tablets

Midodrine Hydrochloride Tablets have a defective container with inadequately sealed blister packaging.

Moderate risk, FDA, Packaging defect

2 recalls that day

Acme United BZK Antiseptic Towelettes and Hand Sanitizing Wipes

Acme United BZK Antiseptic Towelettes and Hand Sanitizing Wipes have CGMP deviations.

Moderate risk, FDA, Manufacturing problem

Harbin Jixianglong Biotech Semaglutide

Semaglutide was distributed before process validation and bacterial endotoxin method validation were completed.

Moderate risk, FDA, Manufacturing problem

1 recall that day

Teva Metoprolol Succinate Extended-Release Tablets

Teva Pharmaceuticals Metoprolol Succinate Extended-Release Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

2 recalls that day

Agebox iKids-Growth Day and Night Formula Capsules

Agebox iKids-Growth (Day Formula) capsules contain undeclared ibutamoren.

Moderate risk, FDA, Hidden drug ingredient

Wizcure Pharmaa Eye Drops and Fluorescein Sodium Ophthalmic Strips

Several eye products, including Vista Tears, Vista Gel, Vista Meibo Tears, Vista Gonio, CHNaO, Bio Glo, and BioGlo, lack assurance of sterility.

Moderate risk, FDA, Sterility problem

3 recalls that day

Slate Run Eptifibatide Injection

The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing.

Low risk, FDA, Labeling error

AvKARE Amantadine HCl Capsules

The capsules failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Adbry (Tralokinumab-Ldrm) Injection

Adbry injection may lack sterility assurance due to particulate matter identified as wool fiber.

Moderate risk, FDA, Sterility problem

1 recall that day

Fresenius Kabi Compounding Acyclovir, Ketamine, Thiamine and Vancomycin Injections

Acyclovir sodium, ketamine HCl, thiamine HCl, and vancomycin HCl injections lack assurance of sterility.

Moderate risk, FDA, Sterility problem

3 recalls that day

Asteria Health Estradiol and Testosterone Sterile Pellets

Estradiol and Testosterone sterile pellets may contain metal particulate matter.

Moderate risk, FDA, Foreign object

Unichem Doxazosin Tablets

Doxazosin Tablets are imprinted with the wrong ID.

Low risk, FDA, Labeling error

Meitheal Pharmaceuticals Cetrorelix Acetate for Injection (Kit)

Cetrorelix Acetate for Injection kits may have missing or duplicated needles.

Moderate risk, FDA, Device defect

2 recalls that day

Accord BioPharma Udenyca Prefilled Syringe

Udenyca injection was stored at room temperature instead of refrigerated.

High risk, FDA, Processing problem

American Health Packaging Oxycodone Hydrochloride Tablets

Oxycodone Hydrochloride Tablets have defective card seals, causing tablets to fall out.

Moderate risk, FDA, Packaging defect

1 recall that day

Pro Numb Tattoo Numbing Spray

Pro Numb Tattoo Numbing Spray has cGMP deviations.

Moderate risk, FDA, Manufacturing problem

5 recalls that day

Taro Diclofenac Sodium Topical Gel 3%

The gel's viscosity is out of specification.

Moderate risk, FDA, Quality testing problem

Granules Trazodone Hydrochloride Tablets

Trazodone Hydrochloride tablets may contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

Stratford Keto-C and Chlorhexidine Ketoconazole Antiseptic Wipes

The product labeled as medicated wipes was found to contain a non-medicated otic flush due to a product mix-up that occurred at the manufacturing level.

Moderate risk, FDA, Labeling error

Green Lumber Natural Fuel For Men Capsules

Green Lumber Natural Fuel For Men capsule contains undeclared tadalafil, a prescription drug, and may cause life-threatening side effects.

High risk, FDA, Hidden drug ingredient

Handelnine Global Rheumacare Capsules

Rheumacare capsules contain lead.

High risk, FDA, Manufacturing problem

2 recalls that day

Unichem Bisoprolol Fumarate and Hydrochlorothiazide Tablets

Bisoprolol Fumarate and Hydrochlorothiazide tablets may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

Central Valley Medicated Cattle Feed Supplements

Cattle feed formulations contain incorrect levels of thiamine and selenium, posing potential selenium toxicity.

High risk, FDA, Wrong nutrient levels

3 recalls that day

Neogen Hycoat Hyaluronate Sodium Sterile Solution

Hycoat Hyaluronate Sodium Sterile Solution may be contaminated with microbes and could cause infection in animals.

High risk, FDA, Sterility problem

Greenstone Methylprednisolone Tablets Dosepak

Methylprednisolone tablets have incorrect dosing information on the blister foil.

Moderate risk, FDA, Labeling error

Novadoz Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution may contain more impurities than allowed.

Low risk, FDA, Drug impurity

1 recall that day

Sato INON ACE Antacid Tablets

Failed Disintegration Specifications: above the time expected.

Moderate risk, FDA, Quality testing problem

1 recall that day

Haleon Parodontax Active Gum Health Mouthwash

Parodontax mouthwash may have missing or illegible lot and expiration date coding on the bottles.

Low risk, FDA, Labeling error

1 recall that day

Baxter Sterile Water for Irrigation

Sterile Water for Irrigation contains plastic particles from the bottle rim floating into the solution.

Moderate risk, FDA, Foreign object

1 recall that day

Zydus Pharmaceuticals Icosapent Ethyl Capsules

Zydus Pharmaceuticals Icosapent Ethyl capsules may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

2 recalls that day

Rising Pharmaceuticals Furosemide Tablets

Furosemide Tablets contain a foreign substance.

Moderate risk, FDA, Foreign object

Specialty Process Labs Thyroid USP

Thyroid, USP may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

1 recall that day

Cipla Diclofenac Sodium Topical Gel 1%

Diclofenac Sodium Topical Gel, 1% failed pH specifications.

Low risk, FDA, Quality testing problem

2 recalls that day

Cipla USA Lanreotide Injection

Lanreotide Injection contains particulate matter.

Moderate risk, FDA, Foreign object

ADM Animal Nutrition MasterPlex 75P 30/30 RU

MasterPlex 75P medicated feed has incorrect labeling that can cause monensin and urea toxicity.

High risk, FDA, Ended, Chemical contamination

5 recalls that day

Encon Safety Products Aquarion Preserved Cartridges

The cartridges have cGMP deviations.

Moderate risk, FDA, Manufacturing problem

Advanced Pharmaceutical Technology TESTO-100 CIII Testosterone Pellets

Testo-100 Ciii (testosterone 100 mg) pellets may be contaminated with microbes, lacking assurance of sterility.

Moderate risk, FDA, Sterility problem

Sun Pharmaceutical Clindamycin Phosphate Topical Solution

Taro may contain more impurities than allowed.

Low risk, FDA, Drug impurity

Alvogen Levothyroxine Sodium Tablets Thy-Tabs

Levothyroxine Sodium Tablets, USP, Thyro-Tabs may contain 88 mcg tablets instead of 150 mcg tablets.

Moderate risk, FDA, Labeling error

Gold Star Distribution Advil, Aleve, Tylenol and More Over-the-Counter Medicines

Gold Star Distribution medicines have CGMP deviations.

Moderate risk, FDA, Manufacturing problem

1 recall that day

Taro Pharmaceuticals Fluocinolone Acetonide Topical Solution

Taro Pharmaceuticals Inc. Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles may contain more impurities than allowed.

Low risk, FDA, Drug impurity