CLASS II Drug recall · Reported 12 Mar 2014 · FDA Enforcement Report
Teva Dextroamphetamine Saccharate, Amphetamine Asparate recalled
Teva Pharmaceuticals USA is recalling Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and, distributed nationwide in the US. The recall was initiated on 24 Jan 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-1094-2014
- FDA event ID
- 67412
- Recalling firm
- Teva Pharmaceuticals USA, Horsham, PA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jan 2014
- FDA classified
- 28 Feb 2014
- Reported
- 12 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- ADHD Medication
Timeline
| 24 Jan 2014 | Recall initiated by company | |
| 28 Feb 2014 | Classified by FDA | +35 days |
| 12 Mar 2014 | 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
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
Product as listed by the FDA
Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
Which lots are affected?
Lot # 34017575A, Exp. 10/16.
Where was it sold?
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 67412This product is part of a recall event; the main page for the event is Teva Hydroxyzine Pamoate Capsules, USP, 100 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Teva Hydroxyzine Pamoate Capsules, USP, 100 mg recalledHydroxyzine Pamoate | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Teva Ethambutol Hydrochloride Tablets, USP, 400 mg recalled | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Teva Hydroxyzine Pamoate Capsules, USP, 25 mg recalledHydroxyzine Pamoate | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Teva Pharmaceuticals USA
All 280| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Dextroamphetamine Saccharate recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |