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

Is NDC 0409-3365-11 recalled?

Hydromorphone Hydrochloride

Yes — this exact package was recalled

1 FDA recall names the code 0409-3365-11 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.

Active ingredient
Hydromorphone Hydrochloride
Strength
HYDROMORPHONE HYDROCHLORIDE 2 mg/mL
Form
Injection, Solution · Intramuscular, Intravenous, Subcutaneous
Labeler
Hospira, Inc.
Type
Human Prescription Drug · DEA CII
Product code
0409-3365

Recalls naming this package

Class II · Moderate risk

HYDROmorphone HCl Injection

Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

Terminated Sterility / contamination Pfizer Inc. NDC 0409-3365-11 D-1167-2017

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