Class II · Moderate risk
Moxifloxacin PF
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Ongoing drug recalls - open right now
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Class II · Moderate risk
Broncochem Cold & Tea
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class II · Moderate risk
Broncochem Cold & Flu Syrup Kids
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class I · High risk
Methocarbamol Injection
Presence of Particulate Matter
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Class II · Moderate risk
Clobazam Tablets 10mg
CGMP Deviations: Out of specification for residual solvents.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP 50mcg
CGMP Deviations: potential presence of Burkholderia cepacia complex
Class I · High risk
Arize Herbal Dietary Supplement
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class I · High risk
SCHWINNNG Herbal Dietary Supplement
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class I · High risk
Sustain Herbal Dietary Supplement
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class II · Moderate risk
Terlivaz (terlipressin for injection)
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class II · Moderate risk
Acthar Gel
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class II · Moderate risk
Mesalamine Extended-Release Capsules
Failed Dissolution Specifications: Out of specification for dissolution.
Class I · High risk
To the Moon Capsules
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk
Ram It
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class II · Moderate risk
Lubricant PM Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
CVS Health Lubricant Eye Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Equate Stye Lubricant Eye Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Equate Lubricant Eye Ointment
Lack of Assurance of Sterility
Class III · Low risk
Nortrel 7/7/7
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk
Nortrel (norethindrone and ethinyl estradiol tablets USP)
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class II · Moderate risk
Norepinephrine Bitartrate in 5% Dextrose Injection
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Class II · Moderate risk
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Class III · Low risk
Glimepiride Tablets
Misprint on tablet
Class III · Low risk
Glimepiride Tablets
Misprint on tablet