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

Is NDC 0228-3063-11 recalled?

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate · 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3063-11)

Yes — this exact package was recalled

1 FDA recall names the code 0228-3063-11 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
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
Strength
DEXTROAMPHETAMINE SACCHARATE 3.75 mg/1; AMPHETAMINE…
Form
Capsule, Extended Release · Oral
Labeler
Actavis Pharma, Inc.
Type
Human Prescription Drug · DEA CII
Product code
0228-3063

Recalls naming this package

Class III · Low risk

Dextroamphetamine Saccharate

Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.

Terminated Dissolution failure Actavis Elizabeth LLC NDC 0228-3063-11 D-190-2013

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