CLASS II Drug recall · Reported 5 Nov 2014 · FDA Enforcement Report
Dextroamphetamine Saccharate, Amphetamine Aspartate recalled
Teva Pharmaceuticals U is recalling Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And, distributed nationwide in the US. The recall was initiated on 8 Oct 2014 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-0050-2015
- FDA event ID
- 69483
- Recalling firm
- Teva Pharmaceuticals U, Horsham, PA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Oct 2014
- FDA classified
- 27 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 8 Oct 2014 | Recall initiated by company | |
| 27 Oct 2014 | Classified by FDA | +19 days |
| 5 Nov 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.
Where it was distributed
U.S. Nationwide including Puerto Rico.
Questions about this recall
Is Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And recalled?
Yes. Teva Pharmaceuticals U recalled Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And on 8 Oct 2014. The recall is Class II and its status is Terminated. Recall number D-0050-2015.
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Which lots are affected?
Lot #: 34016373A, Expiry: 7/2016; Lot #: 34016377A, Expiry: 7/2016.
Where was it sold?
U.S. Nationwide including Puerto Rico.
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.
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Other Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
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| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalledDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Lannett Company | Other | OH |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalledDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalledDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Teva Pharmaceuticals U | Other | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalledDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Teva Pharmaceuticals U | Other | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalledDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Teva Pharmaceuticals U | Other | Nationwide |