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Drug recalls

Drug recalls from FDA, newest first.
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2 recalls

Ultimate Forza Male Supplement

Ultimate Forza Male Supplement contains undeclared sildenafil, tadalafil, and dapoxetine, which may lower blood pressure to dangerous levels.

FDA

Neogen Uniprim Powder for Horses

Neogen Uniprim Powder for Horses have a defective container closure.

FDA, Packaging defect

3 recalls

Glenmark Abiraterone Acetate Tablets

Abiraterone Acetate Tablets have a labeling issue.

Moderate risk, FDA, Labeling error

Ritedose Formoterol Fumarate Inhalation Solution

Formoterol Fumarate Inhalation Solution failed impurities and degradation specifications.

Moderate risk, FDA, Drug impurity

Safecor Health Metoclopramide Tablets

Manufacturer is recalling batches due to co-mingled tablet.

Moderate risk, FDA, Foreign object

4 recalls

Strides Pharma Cinacalcet Tablets

Cinacalcet Tablets failed dissolution specifications.

FDA, Drug dissolving problem

AvKARE Amitriptyline Hydrochloride Tablets

Amitriptyline Hydrochloride tablets failed dissolution specifications.

FDA, Drug dissolving problem

Biomedical Data Solutions Ortho Connect Software

Ortho Connect software can incorrectly reject potential discrepant results during result review and export them to the LIS.

Moderate risk, FDA, Software defect

ARUP Laboratories Apheresis Platelets, PAS, Leukocytes Reduced

Apheresis Platelets, PAS, Leukocytes Reduced were not tested to verify residual white blood cell count and pH testing was not performed.

Moderate risk, FDA, Quality testing problem

1 recall

Wedgewood Compounded Veterinary Medications

Compounded veterinary medications may be subpotent or superpotent, posing health risks including ineffective treatment or toxicity.

FDA

1 recall

Right Value Drug Stores Testosterone Cypionate

Testosterone Cypionate, 200 mg/mL, lacks sterility assurance.

Moderate risk, FDA, Sterility problem

2 recalls

American Regent BetaVet Betamethasone Injectable Suspension for Horses

BetaVet betamethasone injectable suspension has defective container seals.

FDA, Packaging defect

Pritam International Toothpastes

Pritam International Toothpastes have CGMP deviations.

Moderate risk, FDA, Manufacturing problem

5 recalls

Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets

Amlodipine and Olmesartan Medoxomil Tablets are out of specification due to dissolution.

Moderate risk, FDA, Drug dissolving problem

Shenzhen Techdow Pharmaceutical Heparin Sodium Injection

Heparin Sodium Injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Mylan Telmisartan and Amlodipine Tablets

Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications.

Low risk, FDA, Wrong drug strength

Hikma Abirtega (Abiraterone Acetate) Tablets

Abirtega (abiraterone acetate) USP tablets failed weight uniformity specifications.

Moderate risk, FDA, Quality testing problem

Pfizer Levoxyl Levothyroxine Sodium Tablets

Levoxyl tablets are subpotent, confirmed by out-of-specification assay during stability testing.

Moderate risk, FDA, Wrong drug strength

1 recall

American Health Packaging Metoclopramide Tablets

Metoclopramide Tablets may contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

4 recalls

Par Pharmaceutical Argatroban Injection

Argatroban Injection may contain particulate matter that can cause life-threatening health consequences.

FDA, Foreign object

Zydus Hydrocortisone Sodium Succinate for Injection

Hydrocortisone Sodium Succinate for Injection failed impurities and degradation specifications.

Moderate risk, FDA, Drug impurity

Teva Metoclopramide Tablets

Metoclopramide Tablets, USP, 5 mg may contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

Houston Rx Sermorelin and Tirzepatide/Niacinamide Injections

Sermorelin sterile injectable solution lacks process control, and Tirzepatide/Niacinamide injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

1 recall

Diagnostic Grifols Erytra Analyzer

The Erytra analyzer can assign incorrect results for an autocancelled and rescheduled test, potentially leading to an incident if a transfusion is performed.

Moderate risk, FDA, Software defect

5 recalls

Par Brevital Sodium Methohexital Sodium

Brevital Sodium contains particulate matter that can cause life-threatening health consequences.

FDA, Foreign object

Sun Pharmaceutical Industries Tretinoin Cream

Tretinoin Cream USP, 0.05% failed impurities and degradation specifications.

Low risk, FDA, Drug impurity

J&J Innovative Medicine Imaavy Injection

Imaavy (nipocalimab-aahu) Injection contains particulate matter.

Moderate risk, FDA, Foreign object

Apothecary Pharma NAD+ and Tirzepatide Injections

Tirzepatide Injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Carolina Infusion Tirzepatide, Semaglutide and Tri-Mix Injectables

Carolina Infusion Tirzepatide, Semaglutide and Tri-Mix Injectables lack assurance of sterility.

Moderate risk, FDA, Sterility problem

2 recalls

Cronus Pharma AnaSed Equine Injection

AnaSed Equine Injection may be discolored.

Moderate risk, FDA, Quality problem

Diagnostic Grifols Erytra and Erytra Eflexis Automated Blood Grouping and Antibody Test Systems

The Erytra blood grouping system has an incorrect configuration that can cause minor variations in titration results.

Low risk, FDA

3 recalls

Preferred Pharmaceuticals Lidocaine Ointment

Lidocaine Ointment USP, 5% failed content uniformity specifications.

Moderate risk, FDA, Quality testing problem

Cipla USA Fosfomycin Tromethamine Granules for Oral Solution

Fosfomycin Tromethamine Granules for Oral Solution failed impurities and degradation specifications.

Moderate risk, FDA, Drug impurity

BioSpectra Tris/Tromethamine

Biospectra Tris/Tromethamine failed stability specifications.

Moderate risk, FDA, Quality testing problem

3 recalls

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced were not tested for pH or platelet yield.

Moderate risk, FDA, Quality testing problem

K.C. Pharmaceuticals Eye Drops

Artificial Tears Sterile Lubricant Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

South Texas Blood & Tissue Center Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were not tested to verify white blood cell count.

Moderate risk, FDA, Quality testing problem

9 recalls

Greenwich Rx Glutathione Injection

Glutathione injection may have 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, which may indicate a problem.

FDA, Quality problem

Glenmark Pharmaceuticals Clindamycin Phosphate Foam, 1%

Clindamycin Phosphate Foam, 1% may leak from a defective container.

Moderate risk, FDA, Packaging defect

Omni Gold Anti-Marks Cream Extra Brightening and Orbi 20

Skin lightening products are contaminated with mercury.

High risk, FDA, Quality testing problem

South Texas Blood & Tissue Pooled Platelets and Red Blood Cells

Pooled platelets and red blood cells were collected from a donor in a malaria endemic area.

Moderate risk, FDA, Blood donor screening

Eversight Illinois Cornea

Cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.

Moderate risk, FDA, Blood donor screening

Eversight Illinois Cornea

Corneas were distributed when donor eligibility was not adequately determined.

Moderate risk, FDA, Blood donor screening

Eversight Illinois Cornea

Corneas were distributed when donor eligibility was not adequately determined.

Moderate risk, FDA, Blood donor screening

4 recalls

Apotex Paroxetine Extended-Release Tablets

Paroxetine Extended-Release Tablets failed dissolution specifications.

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

Microbial contamination of topical product.

Moderate risk, FDA, Contamination

American National Red Cross Apheresis Platelets

Apheresis Platelets lacked documentation of time exposed to the Compound Absorption Device during pathogen reduction.

Low risk, FDA, Contamination