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

Zenatane (isotretinoin)

Failed dissolution specifications - low dissolution results at S3 stage.

Terminated Dissolution failure Dr. Reddy's Laboratories, Inc. NDC 5511-113-81 D-0508-2017
Class III · Low risk

Zenatane (isotretinoin)

Failed dissolution specifications - low dissolution results at S3 stage.

Terminated Dissolution failure Dr. Reddy's Laboratories, Inc. NDC 55111-136-81 D-0507-2017
Class III · Low risk

Zenatane (isotretinoin)

Failed dissolution specifications - low dissolution results at S3 stage.

Terminated Dissolution failure Dr. Reddy's Laboratories, Inc. NDC 55111-137-81 D-0506-2017
Class II · Moderate risk

GlipiZIDE Extended-release tablets

Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.

Terminated Dissolution failure Amerisource Health Services NDC 68084-295-21 D-0520-2017
Class II · Moderate risk

Glipizide extended-release tablets

Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.

Terminated Dissolution failure Actavis Inc NDC 0591-0900-30 D-0476-2017
Class II · Moderate risk

Flucanozole Tablets

Failed Dissolution Specifications; 18 month stability time point

Terminated Dissolution failure Dr. Reddy's Laboratories, Inc. NDC 55111-146-30 D-0452-2017
Class II · Moderate risk

Flucanozole Tablets

Failed Dissolution Specifications; 18 month stability time point

Terminated Dissolution failure Dr. Reddy's Laboratories, Inc. NDC 55111-145-12 D-0451-2017
Class II · Moderate risk

Flucanozole Tablets

Failed Dissolution Specifications; 18 month stability time point

Terminated Dissolution failure Dr. Reddy's Laboratories, Inc. NDC 55111-144-30 D-0450-2017
Class II · Moderate risk

Flucanozole Tablets

Failed Dissolution Specifications; 18 month stability time point

Terminated Dissolution failure Dr. Reddy's Laboratories, Inc. NDC 55111-143-30 D-0449-2017
Class II · Moderate risk

Nadolol Tablets

Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)

Terminated Dissolution failure Sandoz Incorporated NDC 0781-1182-10 D-0236-2017
Class II · Moderate risk

Phenobarbital Tablets

Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point

Terminated Dissolution failure West-Ward Pharmaceuticals Corp. NDC 0143-1455-01 D-1045-2017
Class III · Low risk

Selegiline HCL Tablets USP 5mg

Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.

Terminated Dissolution failure Stason Pharmaceuticals, Inc. NDC 51862-146-06 D-1479-2016