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

Is NDC 66758-0235-31 recalled?

Focalin XR · 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-235-31)

Yes — this exact package was recalled

1 FDA recall names the code 66758-0235-31 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
dexmethylphenidate hydrochloride
Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1
Form
Capsule, Extended Release · Oral
Labeler
Sandoz Inc
Type
Human Prescription Drug · DEA CII
Product code
66758-0235

Recalls naming this package

Class III ยท Low risk

Focalin XR

Labeling: Incorrect or Missing Lot and/or Exp Date

Ongoing Labeling / mix-up Sandoz Inc D-0608-2026

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