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

National Drug Code

Is NDC 45963-0412-61 recalled?

Hydrocortisone and acetic acid otic solution

Yes — this exact package was recalled

1 FDA recall names the code 45963-0412-61 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

Hydrocortisone and acetic acid otic solution

Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).

Terminated Impurity / degradation Actavis Inc NDC 45963-412-61 D-1472-2016

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