Class II · Moderate risk
Methylergonovine Maleate Tablets
Failed Dissolution Specifications
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 II · Moderate risk
Tri-Lo-Sprintec
Failed Dissolution Specifications
Class II · Moderate risk
Methylprednisolone acetate Injectable Suspension
Failed Dissolution Specifications
Class III · Low risk
Mercaptopurine Tablets
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Class II · Moderate risk
Mesalamine Extended-Release Capsules
Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk
Budesonide Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Budesonide Extended-Release Tablets 9mg
Failed Dissolution Specifications
Class II · Moderate risk
Methoxsalen Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Divalproex Sodium Extended-release Tablets
Failed dissolution specifications
Class II · Moderate risk
Penicillamine Tablets USP 250 mg
Failed Dissolution Specifications
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications
Class III · Low risk
Votrient (pazopanib)
Failed Dissolution Specifications
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Ranolazine Extended-Release Tablets 500mg
Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk
Deferasirox Tablets for Oral Suspension
Failed Dissolution Specifications
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablet USP
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablet USP
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablet USP
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class III · Low risk
Bupropion Hydrochloride Extended-Release Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Failed Dissolution Specifications
Class III · Low risk
Nexlizet (bempedoic acid and ezetimibe)
Failed dissolution specifications: below specification results at stability 12-month
Class II · Moderate risk
Rasagiline Tablets 0.5mg
Failed dissolution specifications - results obtained were below spec average.
Class II · Moderate risk
Fingolimod Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Tizanidine Tablets
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Class II · Moderate risk
Tizanidine Tablets USP
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
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