Class II · Moderate risk
Chlorthalidone 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.
- Total recalls
- 405
- Class I (high risk)
- 9
- Currently ongoing
- 73
- Most recent
- Sep 3, 2026
Most-cited firms for this cause
- Dr. Reddy's Laboratories, Inc.48
- Sun Pharmaceutical Industries INC17
- Ascend Laboratories, LLC15
- American Health Packaging14
- Teva Pharmaceuticals USA11
- The Harvard Drug Group10
- Glenmark Pharmaceuticals Inc., USA10
- Zydus Pharmaceuticals (USA) Inc9
Class III · Low risk
Trokendi XR
Failed dissolution specifications.
Class II · Moderate risk
Carton label: Mycophenolate Mofetil for injection
Failed Dissolution Specifications
Class II · Moderate risk
Prasugrel HCI
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Class II · Moderate risk
Paxil CR
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Class II · Moderate risk
Diovan (valsartan)
Failed Dissolution Specifications
Class II · Moderate risk
Acamprosate Calcium
Failed Dissolution Specifications
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Class III · Low risk
Trokendi XR
Failed Dissolution Specifications
Class II · Moderate risk
Chlorthalidone Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Minocycline Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Class II · Moderate risk
GSMS Incorporated
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Class II · Moderate risk
Niacin Extended-release Tablets
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Class II · Moderate risk
Ascend Laboratories
Failed Dissolution Specifications
Class II · Moderate risk
Memantine Hydrochloride Extended-Release
Failed Dissolution Specifications
Class II · Moderate risk
Xanax XR
Failed Dissolution Specifications
Class II · Moderate risk
Amnesteem (Isotretinoin)
Failed Dissolution Specifications
Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Rosuvastatin Tablets
Out of specification for dissolution.
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