Class II · Moderate risk
Phendimetrazine Yellow Tabs 35mg
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
FDA Drug Recalls
832 recalls, newest first
Class II · Moderate risk
Phendimetrazine Yellow Tabs 35mg
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Topiramate 25mg Tabs White/round tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Thyroid Neutral Tabs 2 gr
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Thyroid 1 Gr tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Thyroid 1 Grain Tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Hydrochlorothiazide 50mg tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Hydrochlorothiazide
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Hydrochlorothiazide 25mg tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class III · Low risk
Clobetasol Propionate Cream
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class II · Moderate risk
VILEVEV MB Urinary Antispetic
cGMP deviations
Class II · Moderate risk
Vilamit Mb
cGMP deviations
Class I · High risk
Born Basic.
Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
LUX EOI Hand Sanitizing Gel
CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
Born Basic.
CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
scent theory KEEP CLEAN Moisturizing Hand Sanitizer
CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
scent theory KEEP IT CLEAN
CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class I · High risk
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Cross Contamination with other products: trace amounts of lidocaine
Class III · Low risk
Leucovorin Calcium Tablets USP
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Class I · High risk
STIMATE (desmopressin acetate)
Superpotent Drug
Class I · High risk
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL
Superpotent Drug
Class I · High risk
DDAVP Nasal Spray
Superpotent Drug
Class II · Moderate risk
Mibelas 24 Fe
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class III · Low risk
Clobetasol Propionate Cream USP
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class II · Moderate risk
Fentanyl Citrate Inj.
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.