Class II · Moderate risk Terminated
Gabapentin Capsules
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Acetaminophen and Codeine Phosphate Tablets
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk Terminated
Acetaminophen and Codeine Phosphate Tablets
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk Terminated
Acetaminophen and Codeine Phosphate Tablets
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class I · High risk Terminated
Phytonadione Injectable Emulsion
Reason Defective Container: Recall is due to breaking and shattering of ampules upon opening
Class II · Moderate risk Terminated
fentaNYL Citrate Injection 50 mcg per mL
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
fentaNYL Citrate Injection
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL…
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
fentaNYL Citrate 50 mcg per mL
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
ePHEDrine Sulfate
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
rocuronium Bromide
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
succinylcholine Chloride
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
fentaNYL Citrate 10 mcg per mL
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
HYDROmorphone in 0.9% Sodium Chloride HCl
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
rocuronium Bromide 10 mg per mL 50 mg per 5 mL
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
nICARdipine HCl
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
ePHEDrine Sulfate
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class I · High risk Terminated
Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary…
Reason 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 Terminated
Gentamicin 80mg/60 mL Irrigation
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Advil Liqui-Gel Mini 160+20+20 CT
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk Terminated
Advil Sinus Congestion and Pain/Advil Allergy and Congestion…
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk Terminated
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant…
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk Terminated
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk Terminated
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg…
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.