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

Is NDC 55111-0653-01 recalled?

Sirolimus · 100 TABLET in 1 BOTTLE (55111-653-01)

Yes — this exact package was recalled

2 FDA recalls name the code 55111-0653-01 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.

1 of these recalls is still ongoing.

Active ingredient
Sirolimus
Strength
SIROLIMUS 1 mg/1
Form
Tablet · Oral
Labeler
Dr. Reddy's Laboratories Limited
Type
Human Prescription Drug
Product code
55111-0653

Recalls naming this package

Class III · Low risk

Sirolimus Tablets

Failed impurities/degradation: out of specification result for impurity secorapamycin.

Terminated Impurity / degradation Dr. Reddy's Laboratories, Inc. NDC 55111-653-01 D-1063-2016

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