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

Is NDC 0591-0444-01 recalled?

Guanfacine · 100 TABLET in 1 BOTTLE, PLASTIC (0591-0444-01)

Yes — this exact package was recalled

1 FDA recall names the code 0591-0444-01 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
Guanfacine
Strength
GUANFACINE HYDROCHLORIDE 1 mg/1
Form
Tablet · Oral
Labeler
Actavis Pharma, Inc.
Type
Human Prescription Drug
Product code
0591-0444

Recalls naming this package

Class II ยท Moderate risk

guanFACINE HCl

Labeling: Label Mixup: guanFACINE HCl, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: W002727, EXP: 6/6/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD39588_7, EXP: 5/13/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003873, EXP: 6/2

Terminated Labeling / mix-up Aidapak Services, LLC D-965-2014

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