Class II · Moderate risk Terminated
Diazepam Oral Solution
Reason Failed Impurities/Degradation Specifications: Out of specification results for related substances.
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Terminated
RED MAMMOTH capsules
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
The Red Pill
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
MAC DADDY PURPLE Capsules
Reason Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Class I · High risk Terminated
MAC DADDY RED Capsules
Reason Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Class II · Moderate risk Terminated
Erythromycin Topical Gel USP
Reason Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Class II · Moderate risk Ongoing
Luxury 70% Isopropyl Alcohol
Reason Labeling - product contains undeclared ethyl alcohol
Class II · Moderate risk Ongoing
70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen
Reason Labeling - product contains undeclared ethyl alcohol
Class II · Moderate risk Terminated
Chlorthalidone Tablets USP 25 mg
Reason Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Class II · Moderate risk Ongoing
Methylphenidate Hydrochloride Chewable Tablets
Reason 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 I · High risk Terminated
Paragard T380a
Reason Non-sterility
Class II · Moderate risk Terminated
Prevantics
Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II · Moderate risk Terminated
Prevantics
Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II · Moderate risk Terminated
Prevantics
Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class I · High risk Terminated
MegMan Performance Booster
Reason Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
Morphine Sulfate PF 25 mg/25mL
Reason Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Class I · High risk Terminated
HYDROmorphone HCl PF 10 mg/50 mL
Reason Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Class II · Moderate risk Ongoing
Premium Nature Instant Hand Sanitizer
Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk Ongoing
Premium Nature Instant Hand Sanitizer
Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class I · High risk Terminated
Hard Dawn
Reason Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.
Class I · High risk Terminated
Polymyxin B for Injection USP
Reason Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class II · Moderate risk Terminated
Cystex Tablet
Reason CGMP Deviations
Class II · Moderate risk Terminated
DBI Magnums Tablet
Reason CGMP Deviations
Class II · Moderate risk Terminated
Coated Back Relief Tablet
Reason CGMP Deviations
Class II · Moderate risk Terminated
Legatrin
Reason CGMP Deviations