Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules
Amerisource Health Services is recalling 115 cartons of 25 mg amphetamine extended-release capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of dosing errors with a Schedule II controlled substance.
Plain-English summary
Amerisource Health Services is recalling 115 cartons of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg. The product is identified by Lot 162490, with an expiration date of 9/30/17, and NDC codes 68084-909-32 (carton) and 68084-909-33 (blister). The recall was initiated because of unit dose mispackaging, where blister cavities may contain more than one tablet or capsule.
The affected product was distributed nationwide. This recall is classified as Class II by the FDA, indicating 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.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options if they are currently using this 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 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health P
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Controlled Substance
- Hazard
- Affected units
- 115
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 (2)
- Lot 162490
- exp. 9/30/17
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 →Related recalls
Same manufacturer · Amerisource Health Services
See all →- HighAmerisource Recalls Paroxetine Tablets Due to Foreign Object Presence
FDA (Drugs) · 2017-11-29
- LowAmerisource Recalls Enalapril Maleate Tablets Due to Stability Failures
FDA (Drugs) · 2017-11-22
- ModerateAmerisource Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure
FDA (Drugs) · 2017-03-22
- ModerateCyclosporine Capsules Recalled for Impurity Specification Failures
FDA (Drugs) · 2017-03-08
- ModerateAHP Nifedipine Capsules Recalled for Presence of Foreign Tablets
FDA (Drugs) · 2016-11-30
Same hazard · mispackaging
See all →- HighRitz peanut butter cracker sandwiches recalled over undeclared peanut from mispackaging
FDA (Devices) · 2025-12-31
- HighCasa Mamita churro bites recalled after cheese stick found in bag
FDA (Food) · 2025-08-06
- HighRitz peanut butter cracker 20 count cartons recalled over undeclared peanut
FDA (Food) · 2025-07-30
- HighRitz peanut butter cracker 40 count cartons recalled over undeclared peanut
FDA (Food) · 2025-07-30
- HighRitz cracker sandwich variety packs recalled over undeclared peanut from mispackaging
FDA (Food) · 2025-07-30