Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Terminated
Levetiracetam Tablets USP
Reason Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
Class II · Moderate risk Terminated
DermOtic Oil
Reason Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Class I · High risk Terminated
maXXzen Platinum 12000 capsule
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk Terminated
PremierZEN Platinum 8000 capsule
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk Terminated
PremierZEN Gold 7000 capsule
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class II · Moderate risk Terminated
Diflorasone Diacetate Ointment USP
Reason Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Class III · Low risk Terminated
Readyprep Chg
Reason Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Class II · Moderate risk Terminated
Native Fluoride Toothpaste for Sensitive Teeth
Reason Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Class III · Low risk Terminated
Sirolimus Tablets 1 mg
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
MEDICALLY MINDED Hand Sanitizer Gel
Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk Ongoing
MEDICALLY MINDED Hand Sanitizer Gel
Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class I · High risk Ongoing
MEDICALLY MINDED Hand Sanitizer Gel
Reason Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Class I · High risk Ongoing
MEDICALLY MINDED Hand Sanitizer Gel
Reason Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Class II · Moderate risk Ongoing
MEDICALLY MINDED Hand Sanitizer Gel
Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk Ongoing
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera
Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class I · High risk Terminated
C-Progesterone Oil 100 Mg/Ml
Reason Non-Sterility
Class I · High risk Terminated
Poseidon Platinum 3500 capsule
Reason Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class II · Moderate risk Terminated
Advance Hand Sanitizer
Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk Terminated
ProtectoRx
Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk Terminated
DiBAR LABS Hand Sanitizer
Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class I · High risk Terminated
DiBAR LABS Hand Sanitizer
Reason Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
Class II · Moderate risk Ongoing
Imperia Elita Vitaccino Coffee
Reason Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine