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 III · Low risk

buPROPion Hydrochloride Extended-¿release Tablets USP

Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.

Terminated Dissolution failure Sun Pharma Global Fze NDC 47335-738-86 D-1345-2015
Class III · Low risk

Intermezzo

Failed dissolution specifications

Terminated Dissolution failure Purdue Pharma L.P. NDC 59011-265-30 D-1278-2015
Class II · Moderate risk

Capecitabine Tablets

Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.

Terminated Dissolution failure Mylan Pharmaceuticals Inc NDC 0378-2512-78 D-1217-2015
Class III · Low risk

Disulfiram tablets

Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.

Terminated Dissolution failure Qualitest Pharmaceuticals NDC 0603-3432-21 D1151-2015
Class II · Moderate risk

Levetiracetam

Failed Dissolution Specifications: 6 month time point.

Terminated Dissolution failure Sun Pharma Global Fze D-0386-2015
Class II · Moderate risk

Mercaptopurine Tablets

Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.

Terminated Dissolution failure American Health Packaging NDC 68084-325-21 D-0300-2015
Class II · Moderate risk

Mercaptopurine Tablets

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Terminated Dissolution failure Prometheus Laboratories Inc. NDC 49884-922-02 D-0249-2015
Class II · Moderate risk

Bystolic (nebivolol)

Failed Dissolution Specification; at the 6-month stability time point

Terminated Dissolution failure Forest Pharmaceuticals Inc NDC 0456-1420-07 D-0036-2015
Class II · Moderate risk

Tarceva (erlotinib)

Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.

Terminated Dissolution failure Astellas Pharma US Inc NDC 50242-064-01 D-0008-2015
Class III · Low risk

Nicotine Polacrilex Lozenge

Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.

Terminated Dissolution failure Perrigo Holland Inc D-1558-2014