Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

National Drug Code

Is NDC 54092-0191-12 recalled?

Pentasa · 120 CAPSULE in 1 BOTTLE (54092-191-12)

Yes — this exact package was recalled

1 FDA recall names the code 54092-0191-12 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
mesalamine
Strength
MESALAMINE 500 mg/1
Form
Capsule · Oral
Labeler
Takeda Pharmaceuticals America, Inc.
Type
Human Prescription Drug
Product code
54092-0191

Recalls naming this package

Class II ยท Moderate risk

MESALAMINE CR Capsule

Labeling: Label Mixup; MESALAMINE CR, Capsule, 500 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD21790_7, EXP: 5/1/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-614-2014

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