Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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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

Extended Phenytoin Sodium Capsules

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

Terminated Dissolution failure Amneal Pharmaceuticals of New York, LLC NDC 65162-212-10 D-0876-2023
Class II · Moderate risk

Metoprolol Succinate Extended-Release Tablets

Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.

Terminated Dissolution failure Amerisource Health Services LLC NDC 68001-501-00 D-0269-2023
Class III · Low risk

SINUVA (mometasone furoate)

Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.

Terminated Dissolution failure Intersect ENT, Inc. NDC 10599-003-01 D-0167-2023
Class III · Low risk

Allergy Relief D

Failed dissolution specifications

Terminated Dissolution failure Dr. Reddy's Laboratories, Inc. NDC 49032-273-20 D-0073-2023
Class II · Moderate risk

Irbesartan Tablets

Failed Dissolution Specifications

Terminated Dissolution failure Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-447-90 D-1294-2022
Class II · Moderate risk

Irbesartan Tablets

Failed dissolution specifications.

Terminated Dissolution failure Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-448-90 D-1293-2022
Class II · Moderate risk

Aripiprazole Tablets

Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.

Terminated Dissolution failure Apotex Corp. NDC 60505-2676-8 D-1285-2022
Class II · Moderate risk

Tretinoin Capsules

Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.

Terminated Dissolution failure Teva Pharmaceuticals USA Inc NDC 0555-0808-02 D-1156-2022
Class II · Moderate risk

Zileuton Extended-Release Tablets

Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.

Terminated Dissolution failure Lupin Pharmaceuticals Inc. NDC 68180-169-16 D-1150-2022
Class I · High risk

Anagrelide Capsules USP

Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.

Terminated Dissolution failure Teva Pharmaceuticals USA Inc NDC 0172-5241-60 D-0992-2022