Food, drugs, devices › Amerisource Health Services
Drug recall: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tabl
Amerisource Health Services (Columbus, OH) initiated this drug recall on 24 Aug 2016; FDA lists 10 product records under event 75076, classified Class II.
FDA defines Class II as 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. 46% of the 288 drug enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 18 Dec 2017. Initiation: voluntary: firm initiated. Amerisource Health Services has 13 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Amerisource Health Services, Columbus, OH.
Reason for recall
"Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule"
Distribution
"Product was distributed in the following states: Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1481-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-874-25;… | 221 cartons | Class II | Terminated | 14 Sep 2016 |
| D-1482-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-936-25;… | 2,276 cartons | Class II | Terminated | 14 Sep 2016 |
| D-1483-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 60687-133-25;… | 1,416 cartons | Class II | Terminated | 14 Sep 2016 |
| D-1484-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-943-25;… | 867 cartons | Class II | Terminated | 14 Sep 2016 |
| D-1485-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 60687-154-25;… | 156 cartons | Class II | Terminated | 14 Sep 2016 |
| D-1486-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC… | 834 cartons | Class II | Terminated | 14 Sep 2016 |
| D-1487-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC… | 126 cartons | Class II | Terminated | 14 Sep 2016 |
| D-1488-2016 | 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 Packaging, Columbus, OH --- Carton NDC… | 666 cartons | Class II | Terminated | 14 Sep 2016 |
| D-1489-2016 | 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 Packaging, Columbus, OH ---- Carton NDC… | 115 cartons | Class II | Terminated | 14 Sep 2016 |
| D-1490-2016 | 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 Packaging, Columbus, OH ---- Carton NDC… | 761 cartons | Class II | Terminated | 14 Sep 2016 |
Context
Other enforcement events for Amerisource Health Services
All 13 events for Amerisource Health Services
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed in the following states: Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Dec 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.