The Recall Desk
ModerateFDA (Drugs)·D-1490-2016·Announced 2016-09-14

Amerisource Recalls Mispackaged Adderall XR 30 mg Extended-Release Capsules

Amerisource Health Services is recalling 761 cartons of Adderall XR 30 mg capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a packaging error (mispackaging) that could lead to dosing errors, fitting the criteria for a moderate severity recall without reported injuries.

Plain-English summary

Amerisource Health Services is recalling 761 cartons of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg. The product is distributed under NDC 68084-887-32 (carton) and NDC 68084-887-33 (blister). The recall involves specific lots: 152418 (exp. 12/31/16), 153544 (exp. 3/31/17), and 154835 (exp. 5/31/17).

The recall was initiated because of unit dose mispackaging, where blister cavities may contain more than one tablet or capsule. This packaging error poses a risk of patients or caregivers administering an incorrect dose of the medication. The product was distributed nationwide.

Consumers and healthcare providers should check their inventory for the affected NDCs and lot numbers. If the product is found, it should be quarantined and returned to the distributor or manufacturer for credit. Patients should consult their healthcare provider if they have concerns about their medication supply or dosing.

The recalled product

Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 30 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Pa
Affected units
761

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot 152418
  • exp. 12/31/16
  • lot 153544
  • exp. 3/31/17
  • lot 154835
  • exp. 5/31/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Amerisource Health Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →