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

Is NDC 68084-0446-11 recalled?

Nitrofurantoin Capsules

Yes — this exact package was recalled

1 FDA recall names the code 68084-0446-11 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 III · Low risk

Nitrofurantoin Capsules

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

Terminated Dissolution failure American Health Packaging NDC 68084-446-11 D-0880-2022
Class III · Low risk

Nitrofurantoin Capsules USP

Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."

Terminated Cross-contamination American Health Packaging NDC 68084-446-01 D-0273-2019

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