Class II · Moderate risk
Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine
GMP Deviations: inadequate manufacturing control processes
FDA drug recalls in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
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
Class I · High risk
diphenoxylate hydrochloride and atropine sulfate tablets
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
ROCuronium Bromide 10 mg per mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag
Lack Of Assurance Of Sterility.
Class II · Moderate risk
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL…
Lack Of Assurance Of Sterility.
Class II · Moderate risk
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag
Lack Of Assurance Of Sterility.
Class II · Moderate risk
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total…
Lack Of Assurance Of Sterility.
Class II · Moderate risk
fentaNYL as citrate 2 mcg / mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125%
Lack Of Assurance Of Sterility.
Class II · Moderate risk
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL
Lack Of Assurance Of Sterility.