Class II · Moderate risk
Age Back
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
FDA drug recalls in 2020
Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
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
Class II · Moderate risk
fentaNYL Citrate Injection 50 mcg per mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
fentaNYL Citrate Injection
Firm is recalling 46 lots of various products because of a lack of sterility assurance.