Class III · Low risk
Montelukast Sodium Chewable Tablets
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose.
405 FDA drug recalls with this cause, newest first.
These recalls happen when a tablet or capsule does not dissolve the way its specification requires. Because dissolution controls how the drug is released, a failure can mean a patient absorbs it too slowly, too quickly, or not at all - a particular concern for extended-release products, where the release profile is the whole point.
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class II · Moderate risk
Raloxifene Hydrochloride Tablets
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Class II · Moderate risk
Prasugrel Tablets 5 mg
Failed Dissolution Specification: Low out of specification dissolution results.
Class III · Low risk
minolira (minocycline hydrochloride)
Failed Dissolution Specifications:
Class II · Moderate risk
Carbamazepine
Failed Dissolution Specifications
Class II · Moderate risk
Bexarotene Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Macrobid Urinary Tract Anitbacterial
Failed dissolution specifications
Class II · Moderate risk
Nitrofurantoin Monohydrate/Macrycrystals Capsules
Failed dissolution specifications
Class II · Moderate risk
Atorvastatin Calcium Tablet USP 80 mg
Failed Dissolution Specifications
Class II · Moderate risk
Keppra (levetiracetam)
Failed Dissolution Specifications.
Class II · Moderate risk
Tamsulosin Hydrochloride Capsules
Failed Dissolution Specifications
Class I · High risk
Drospirenone and Ethinyl Estradiol Tablets
Failed dissolution specifications : failed results at the 3-month stability time point.
Class II · Moderate risk
Zileuton Extended-Release Tablets
Failed Dissolution Specifications: Out of specification result for dissolution.
Class II · Moderate risk
ZYFLO CR (zileuton)
Failed Dissolution Specifications: Out of specification result for dissolution.
Class II · Moderate risk
GlipiZIDE Extended-release Tablets
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Class III · Low risk
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Failed Dissolution Specifications
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; 9-monthstability timepoint
Class II · Moderate risk
Tamsulosin Hydrochloride Capsules
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Class III · Low risk
Oxybutynin Chloride
Failed Dissolution Specifications
Class III · Low risk
Temozolomide Capsules
Failed dissolution specifications
Class II · Moderate risk
Divalproex Sodium Extended-release Tablets
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Class III · Low risk
Diltiazem HCl CD capsules
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
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