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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
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Date
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3 recalls that day

Cipla USA Fosfomycin Tromethamine Granules for Oral Solution

Fosfomycin Tromethamine Granules for Oral Solution may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

BioSpectra Tris/Tromethamine

Biospectra Tris/Tromethamine failed stability specifications.

Moderate risk, FDA, Quality testing problem

1 recall that day

K.C. Pharmaceuticals Eye Drops

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

Moderate risk, FDA, Sterility problem

5 recalls that day

Greenwich Rx Glutathione Injection

Glutathione Injection may contain elevated endotoxin levels, which could cause fevers, hypotension, inflammatory reactions, anaphylactic shock and death.

High risk, FDA, Sterility problem

PHP Animal Health Pet Drops Lubricant Eye Drops

PHP Animal Health Pet Drops Lubricant Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Amazon Extra Strength Acetaminophen Caplets

Acetaminophen Extra Strength caplets have discolored tablets.

Moderate risk, FDA, Quality problem

Glenmark Pharmaceuticals Clindamycin Phosphate Foam, 1%

Clindamycin Phosphate Foam, 1%, for topical use, comes in a defective container that can leak.

Moderate risk, FDA, Packaging defect

Omni Gold Anti-Marks Cream Extra Brightening and Orbi 20

Orbi 20 Whitening Cream and Omni Gold Anti-Marks Cream are contaminated with mercury.

High risk, FDA, Quality testing problem

3 recalls that day

Apotex Paroxetine Extended-Release Tablets

Apotex Paroxetine Extended-Release Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Endo USA Buprenorphine Hydrochloride Injection

Buprenorphine Hydrochloride Injection can crystallize.

Moderate risk, FDA, Quality problem

Rugby Benzoyl Peroxide Wash

Benzoyl Peroxide Wash is contaminated with microbes.

Moderate risk, FDA, Contamination

3 recalls that day

FOCUS PI Hypromellose 0.7% Formula

Focus PI Hypromellose 0.7% Formula lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Zoladex (Goserelin) Implant

Zoladex (goserelin) implant was exposed to non-temperature-controlled conditions for 25.5 hours.

Moderate risk, FDA, Processing problem

Amneal Pharmaceuticals Estradiol Gel

Estradiol Gel packets may be empty or partially full.

Moderate risk, FDA, Packaging defect

1 recall that day

Ajanta Pharma Ranolazine Extended-Release Tablets

Ajanta Pharma USA Inc. Ranolazine Extended-Release Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

1 recall that day

Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops

Clear Eyes Redness Relief eye drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

2 recalls that day

Macleods Olanzapine Tablets

Olanzapine Tablets, USP 5 mg, 30-count bottle may contain more impurities than allowed.

Low risk, FDA, Drug impurity

Amneal Exenatide Injection

Exenatide Injection prefilled pens may contain no medication.

Moderate risk, FDA, Device defect

2 recalls that day

Niwali Tejocote Capsules and Niwali Tejocote Pieces

Niwali Tejocote Capsules and Pieces contain yellow oleander, which can cause severe or fatal health effects.

Not yet rated, FDA

Sterling Pharmaceutical Services Lubricant Eye Drops and Ointments

Sterling Pharmaceutical Services Lubricant Eye Drops and Ointments lack assurance of sterility.

Moderate risk, FDA, Sterility problem

2 recalls that day

Endo Dexmedetomidine HCl in 0.9% Sodium Chloride Injection

Dexmedetomidine HCL in 0.9% Sodium Chloride Injection contains particulate matter that can cause life-threatening health consequences.

High risk, FDA, Foreign object

Menow Sunscreen Pressed Powder SPF35 PA+++

The product has cGMP deviations.

Moderate risk, FDA, Manufacturing problem

3 recalls that day

ICU Medical 0.9% Sodium Chloride Injection

0.9% Sodium Chloride Injection may be mixed up with potassium chloride.

High risk, FDA, Labeling error

Hospira Dopamine HCl Injection

Dopamine HCl injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Dechra Veterinary Products Puralube Vet Ointment

The product has cGMP deviations. It may not be sterile.

Moderate risk, FDA, Manufacturing problem

1 recall that day

Inventia Healthcare Chlorthalidone Tablets

Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

2 recalls that day

Taro Nystatin Cream

The cream failed stability specifications.

Moderate risk, FDA, Quality testing problem

Amneal Phytonadione Injectable Emulsion

The product failed impurities and degradation specifications.

Low risk, FDA, Drug impurity

1 recall that day

Safecor Health Fluphenazine HCl Oral Elixir

Safecor Health Fluphenazine HCl Oral Elixir failed stability specifications.

Moderate risk, FDA, Quality testing problem

2 recalls that day

Centric Compounding Glutathione, Myers Cocktail and Tri-Immune Boost Injections

Centric Compounding injections were compounded with a Glutathione API containing elevated endotoxin levels.

High risk, FDA, Sterility problem

Taro Lidocaine Ointment

The product failed content uniformity specifications.

Moderate risk, FDA, Quality testing problem

1 recall that day

OurPharma FentaNYL Citrate Injection Solution

FentaNYL Citrate Injection solution has a labeling discrepancy between the bag expiry and product expiry.

Moderate risk, FDA, Labeling error

2 recalls that day

ImprimisRx NJ Povidone Iodine and Proparacaine Ophthalmic Solution

Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution may be weaker than labeled.

Low risk, FDA, Wrong drug strength

Ajanta Pharma Fluphenazine Hydrochloride Tablets

Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles may contain more impurities than allowed.

Low risk, FDA, Drug impurity

1 recall that day

Business Pill and Branch Manager for Men

Business Pill and Branch Manager for Men dietary supplements contain undeclared yohimbine, which can cause severe hypertension and heart problems.

Not yet rated, FDA

3 recalls that day

American Regent Epinephrine Injection

Presence of Particluate Matter and Lack of Assurance of Sterility.

High risk, FDA, Sterility problem

Trokendi XR (Topiramate) Extended-Release Capsules

Trokendi XR, (topiramate) extended-release capsules may not dissolve properly in the body.

Low risk, FDA, Drug dissolving problem

Mylan Mycophenolate Mofetil for Injection

Mylan Institutional LLC Mycophenolate Mofetil for injection, USP, 500 mg/vial may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

1 recall that day

Teva Trazodone Hydrochloride Tablets

TraZODone Hydrochloride Tablets contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

2 recalls that day

Broadway Joe's Pain Cream

Broadway Joe's Pain Cream may be contaminated due to raw material contamination.

Moderate risk, FDA, Contamination

Sage Chlorhexidine Gluconate Cloths

2% Chlorhexidine Gluconate Cloth, Non-sterile, 6 Disposable cloths can cause cross contamination with other products.

Moderate risk, FDA, Contamination

2 recalls that day

Lipofit Extreme Fat Burner 2.0

Lipofit Extreme Fat Burner 2.0 contains undeclared fluoxetine and DNP, which can cause serious and life-threatening effects.

Not yet rated, FDA

American Health Packaging Buprenorphine Sublingual Tablets

Buprenorphine Sublingual Tablets have a label mix-up.

Low risk, FDA, Labeling error

6 recalls that day

GSMS Prasugrel HCI Tablets

Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Revcovi (Elapegademase-Lvlr) Injection

The product failed stability specifications for its protein concentration profile.

Low risk, FDA, Quality testing problem

Mylan Prasugrel Tablets

Mylan Prasugrel Tablets, USP, 10mg may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

The One SPF 50 Invisible Sunscreen Gel

The One SPF 50 Invisible Sunscreen Gel may not reliably provide the SPF 50 protection stated on the label.

Moderate risk, FDA, Wrong drug strength

Bionpharma Doxylamine Succinate and Pyridoxine HCl Delayed-Release Tablets 10 mg/10 mg

Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets may contain foreign tablets or capsules.

Low risk, FDA, Foreign object

Baxter Vancomycin, Insulin, Daptomycin and Other Injections

Baxter Vancomycin, Insulin, Daptomycin and Other Injections have CGMP Deviations.

Moderate risk, FDA, Manufacturing problem

2 recalls that day

B. Braun 0.9% Sodium Chloride Injection

0.9% Sodium Chloride Injection contains particulate matter that can cause life-threatening health consequences.

High risk, FDA, Foreign object