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

Is NDC 68084-0530-01 recalled?

QUETIAPINE Fumarate Tablets 25mg 100 Tablets

Yes — this exact package was recalled

1 FDA recall names the code 68084-0530-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.

Recalls naming this package

Class II · Moderate risk

QUETIAPINE Fumarate Tablets 25mg 100 Tablets

Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.

Terminated Dissolution failure American Health Packaging NDC 68084-530-01 D-802-2013

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler