Amerisource Recalls Mispackaged Adderall XR 20 mg Extended-Release Capsules
Amerisource Health Services is recalling 666 cartons of Adderall XR 20 mg capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 unit dose mispackaging which could lead to dosing errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Amerisource Health Services is recalling 666 cartons of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg. The affected product is packaged and distributed by American Health Packaging in Columbus, Ohio, and is identified by NDC 68084-832-25 for cartons and NDC 68084-832-95 for blisters.
The recall is being conducted because of unit dose mispackaging, where blister cavities may contain more than one tablet or capsule. The affected lots are 152325 (exp. 12/31/16) and 154834 (exp. 5/31/17). The product was distributed nationwide.
Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Consumers should consult their healthcare provider if they have concerns about their medication.
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 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health…
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Controlled Substance
- Hazard
- Affected units
- 666
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 (4)
- Lot 152325
- exp. 12/31/16
- lot 154834
- 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.
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