CLASS II Drug recall · Reported 14 Sep 2016 · FDA Enforcement Report
Dextroamphetamine Saccharate recalled by Amerisource Health Services
Amerisource Health Services is recalling Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine, distributed nationwide in the US. The recall was initiated on 24 Aug 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1483-2016
- FDA event ID
- 75076
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2016
- FDA classified
- 2 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- ADHD Medication
Timeline
| 24 Aug 2016 | Recall initiated by company | |
| 2 Sep 2016 | Classified by FDA | +9 days |
| 14 Sep 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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; Blister NDC 60687-133-95
Where it was distributed
Product was distributed in the following states: Nationwide
Questions about this recall
Is Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine recalled?
Yes. Amerisource Health Services recalled Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine on 24 Aug 2016. The recall is Class II and its status is Terminated. Recall number D-1483-2016.
Why was it recalled?
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Which lots are affected?
Lot 150950, exp. 3/31/17 and lot 154813, exp. 5/31/2017
Where was it sold?
Product was distributed in the following states: Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |