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

Is NDC 43975-0278-10 recalled?

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate · 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-278-10)

Yes — this exact package was recalled

1 FDA recall names the code 43975-0278-10 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 and Amphetamine Sulfate
Strength
AMPHETAMINE SULFATE 2.5 mg/1; AMPHETAMINE DL-ASPARTATE…
Form
Capsule, Extended Release · Oral
Labeler
ANI Pharmaceuticals, Inc.
Type
Human Prescription Drug · DEA CII
Product code
43975-0278

Recalls naming this package

Class III · Low risk

Dextroamphetamine Saccharate

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Terminated Labeling / mix-up ANI Pharmaceuticals, Inc. NDC 43975-278-10 D-0044-2021

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

  • 43975-0253 See recall 3
  • 43975-0252 See recall 1
  • 43975-0256 See recall 1
  • 43975-0257 See recall 1
  • 43975-0277 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1
  • 43975-0279 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1