Class III · Low risk
Phytonadione Tablets 5 mg
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Ketamine HCl Injection Solution
Labeling: Incorrect Exp. Date: Incorrect BUD.
Class III · Low risk
Phytonadione Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Mephyton (Phytonadione)
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class III · Low risk
Levetiracetam Tablets USP
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
DermOtic Oil
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
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
Daytrana (methylphenidate transdermal system)
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
maXXzen Platinum 12000 capsule
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk
PremierZEN Platinum 8000 capsule
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk
PremierZEN Gold 7000 capsule
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class II · Moderate risk
Diflorasone Diacetate Ointment USP
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Class III · Low risk
Readyprep Chg
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Class II · Moderate risk
Native Fluoride Toothpaste for Sensitive Teeth
Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Class III · Low risk
Sirolimus Tablets 1 mg
Failed Impurities/Degradation Specifications
Class II · Moderate risk
MEDICALLY MINDED Hand Sanitizer Gel
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
MEDICALLY MINDED Hand Sanitizer Gel
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
MEDICALLY MINDED Hand Sanitizer Gel
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
MEDICALLY MINDED Hand Sanitizer Gel
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
MEDICALLY MINDED Hand Sanitizer Gel
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
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera
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
C-Progesterone Oil 100 Mg/Ml
Non-Sterility
Class I · High risk
Poseidon Platinum 3500 capsule
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.