Class II · Moderate risk
Asma Stopper
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
FDA Drug Recalls
832 recalls, newest first
Class II · Moderate risk
Age Stop Ex
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Age Back
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Acne Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Acne Cystic
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Acupuncture
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class I · High risk
Tetracycline HCL Capsules
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Class I · High risk
Tetracycline HCL Capsules
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Class III · Low risk
Tacrolimus Capsules
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Class II · Moderate risk
Dermatone (avobenzone, homosalate, octisalate, and octocrylene)
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Class II · Moderate risk
Dermatone (avobenzone, homosalate, octisalate, and octocrylene)
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Class II · Moderate risk
Draximage Dtpa
Failed Stability Specifications
Class II · Moderate risk
Nystatin Oral Suspension
SubPotent Drug: Low out-of-specification results for assay testing.
Class II · Moderate risk
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Class II · Moderate risk
Methotrexate
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Class II · Moderate risk
Oxycodone and Acetaminophen Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Phentermine Hydrochloride Capsules
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Mirtazapine Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Simvastatin Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Levetiracetam Tablets USP 750 mg 120-count bottles
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Gabapentin Capsules
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Acetaminophen and Codeine Phosphate Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Acetaminophen and Codeine Phosphate Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Acetaminophen and Codeine Phosphate Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class I · High risk
Phytonadione Injectable Emulsion
Defective Container: Recall is due to breaking and shattering of ampules upon opening