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

Is NDC 0591-0369-01 recalled?

Loxapine · 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0369-01)

Yes — this exact package was recalled

2 FDA recalls name the code 0591-0369-01 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.

Active ingredient
Loxapine
Strength
LOXAPINE SUCCINATE 5 mg/1
Form
Capsule
Labeler
Actavis Pharma, Inc.
Type
Drug for Further Processing
Product code
0591-0369

Recalls naming this package

Class II · Moderate risk

Loxapine

Labeling: Label Mixup: LOXAPINE, Capsule, 5 mg may have potentially been mislabeled as the following drug: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD46426_1, EXP: 5/15/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-961-2014
Class III · Low risk

Loxapine Capsules USP

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Terminated Labeling / mix-up Watson Laboratories Inc NDC 00591-0369-01 D-1399-2012

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