CLASS II Drug recall · Reported 10 Jun 2020 · 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 22 May 2020 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-1285-2020
- FDA event ID
- 85712
- Recalling firm
- Teva Pharmaceuticals U, Parsippany, NJ
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 May 2020
- FDA classified
- 4 Jun 2020
- Reported
- 10 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- ADHD Medication
Timeline
| 22 May 2020 | Recall initiated by company | |
| 4 Jun 2020 | Classified by FDA | +13 days |
| 10 Jun 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some bottles may contain mixed strengths of the product.
Product as listed by the FDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02
Where it was distributed
Nationwide within the United State and 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 22 May 2020. The recall is Class II and its status is Terminated. Recall number D-1285-2020.
Why was it recalled?
Some bottles may contain mixed strengths of the product.
Which lots are affected?
Lot #: 42614718, Exp. date 02/2021
Where was it sold?
Nationwide within the United State and 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 |
|---|---|---|---|---|---|
| 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 Sacharate, Amphetamine Aspartate recalledDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Aurobindo Pharma USA | Potency & Assay | Nationwide |