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

Is NDC 64764-0240-60 recalled?

Amitiza · 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-240-60)

Yes — this exact package was recalled

2 FDA recalls name the code 64764-0240-60 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
lubiprostone
Strength
LUBIPROSTONE 24 ug/1
Form
Capsule, Gelatin Coated · Oral
Labeler
Takeda Pharmaceuticals America, Inc.
Type
Human Prescription Drug
Product code
64764-0240

Recalls naming this package

Class II · Moderate risk

Amitiza (lubiprostone)

Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.

Terminated Labeling / mix-up Mallinckrodt Pharmaceuticals NDC 64764-240-60 D-1295-2019
Class II · Moderate risk

LUBIPROSTONE Capsule

Labeling: Label Mixup; LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD21790_43, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD21846_46, EXP: 5/1/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD39858_1, EXP: 5/16/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-697-2014

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