Class II · Moderate risk
BCAAs (Leucine/Iso-Leucine/Valine)
Lack of Assurance of Sterility
FDA Drug Recalls
2,357 recalls · Class II, newest first
Class II · Moderate risk
Ascorbic Acid 500mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Alpha Lipoic Acid 25mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
All Over-The-Counter
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
Class II · Moderate risk
Luxury 70% Isopropyl Alcohol
Labeling - product contains undeclared ethyl alcohol
Class II · Moderate risk
70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen
Labeling - product contains undeclared ethyl alcohol
Class II · Moderate risk
Methylphenidate Hydrochloride Chewable Tablets
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
Class II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk
Lexette (halobetasol propionate)
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Class II · Moderate risk
Medroxyprogesterone Acetate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
Class II · Moderate risk
Lidocaine Hydrochloride
Superpotent Drug: Minimally superpotent
Class II · Moderate risk
Diclofenac Sodium Topical Solution
Defective container: Out of specification for container integrity leading to bottles leaking.
Class II · Moderate risk
The Natural Dentist Healthy Balance Peppermint Sage
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Class II · Moderate risk
Meclizine HCl Tablets
Labeling: Incorrect Instructions
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Combipatch
Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk
Combipatch
Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk
Erythromycin Topical Solution USP
Defective container: possibility for lack of seal integrity.