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

Is NDC 0409-1162-19 recalled?

Bupivacaine Hydrochloride

Yes — this exact package was recalled

1 FDA recall names the code 0409-1162-19 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
Bupivacaine Hydrochloride
Strength
BUPIVACAINE HYDROCHLORIDE 5 mg/mL
Form
Injection, Solution · Epidural, Intracaudal, Perineural
Labeler
Hospira, Inc.
Type
Human Prescription Drug
Product code
0409-1162

Recalls naming this package

Class I · High risk

0.5% Bupivacaine Hydrochloride Injection

Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

Terminated Labeling / mix-up Pfizer, INC NDC 0409-1162-19 D-0626-2021
Class II · Moderate risk

Bupivacaine HCl Inj.

Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-1162-02 D-1588-2014

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