Class II · Moderate risk
Oxycodone and Acetaminophen Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
FDA Drug Recalls
18,003 recalls, newest first
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.
Class II · Moderate risk
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
fentaNYL Citrate 50 mcg per mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
rocuronium Bromide
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
succinylcholine Chloride
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
fentaNYL Citrate 10 mcg per mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
HYDROmorphone in 0.9% Sodium Chloride HCl
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
rocuronium Bromide 10 mg per mL 50 mg per 5 mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
nICARdipine HCl
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class I · High risk
Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary…
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction
Class II · Moderate risk
Gentamicin 80mg/60 mL Irrigation
Lack of Assurance of Sterility