Class III · Low risk
Fluconazole Injection
Superpotent
FDA Drug Recalls
18,003 recalls, newest first
Class I · High risk
Nexterone (amiodarone HCl)
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Class III · Low risk
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets
Failed Stability Specifications
Class I · High risk
GERICARE Eyewash
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Clozapine Tablets USP
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Class II · Moderate risk
Maximum Strength Zephrex-D
Microbial Contamination of Non-Sterile Products
Class III · Low risk
Ciprofloxacin in Dextrose
Superpotent
Class III · Low risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class III · Low risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class III · Low risk
bupPROPion HCL Extended-Release Tablets
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
Class II · Moderate risk
Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength PreTAT by TAT BALM Gel
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
ePHEDrine Sulfate In 0.9% Sodium Chloride
Subpotent Drug
Class III · Low risk
Meclizine hydrochloride tablets USP
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Class III · Low risk
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol
Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
Class I · High risk
Midazolam Injection
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Class II · Moderate risk
Estriol
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk
Dutasteride and Tamsulosin HCl Capsules
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Class II · Moderate risk
Paroxetine Tablets
Presence of Foreign Tablets/Capsules.
Class II · Moderate risk
Succinylcholine 20 MG/ML INJ
Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
Class II · Moderate risk
Zoloft (sertraline HCl)
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent