Class III · Low risk
Sirolimus Oral Solution
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
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
Nitrofurantoin Capsules
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class II · Moderate risk
Xanax XR (alprazolam)
Failed Dissolution Specifications: low out of specification results for dissolution.
Class II · Moderate risk
alprazolam XR extended-release tablets
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Preferred Pharmaceuticals
Out of specification results observed in dissolution during long term stability testing.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules
Failed Dissolution Specifications; during long term stability testing.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules
Failed Dissolution Specifications; during long term stability testing.
Class II · Moderate risk
Paliperidone Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Tretinoin Capsules
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Class III · Low risk
Leader
Failed Dissolution Specifications
Class III · Low risk
CVS Health
Failed Dissolution Specifications
Class III · Low risk
Qc Quality Choice
Failed Dissolution Specifications
Class III · Low risk
equate
Failed Dissolution Specifications
Class III · Low risk
Dr. Reddys
Failed Dissolution Specifications
Class III · Low risk
Kroger
Failed Dissolution Specifications
Class III · Low risk
Rite Aid Pharmacy
Failed Dissolution Specifications
Class III · Low risk
Rugby
Failed Dissolution Specifications
Class III · Low risk
Wal-Fex D
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Carbamazepine Tablets
Failed Dissolution Specifications
Class III · Low risk
Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
Allergy Relief D Fexofenadine HCl
Failed dissolution specifications
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.