CLASS II Drug recall · Reported 11 Mar 2015 · FDA Enforcement Report
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg recalled
Actavis Elizabeth is recalling Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, distributed nationwide in the US. The recall was initiated on 10 Feb 2015 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-0395-2015
- FDA event ID
- 70522
- Recalling firm
- Actavis Elizabeth, Elizabeth, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Feb 2015
- FDA classified
- 27 Feb 2015
- Reported
- 11 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 10 Feb 2015 | Recall initiated by company | |
| 27 Feb 2015 | Classified by FDA | +17 days |
| 11 Mar 2015 | 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
Failed Dissolution Specifications
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 Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #: 2020E141, Exp 07/15
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 12 Oct 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 Actavis Elizabeth
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | NIFEdipine Capsules USP, 10 mg recalled by Actavis Elizabeth | Actavis Elizabeth | Other | NJ |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
Other Dextroamphetamine recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dextroamphetamine Saccharate recalled by Lannett CompanyDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Lannett | Packaging Defects | Nationwide |
| Drug | CLASS II | Xelstrym (dextroamphetamine) transdermal system recalledXelstrym | Noven Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS I | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg recalledZenzedi | Azurity Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg recalled | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Tablets USP, 5 mg recalled | Impax Laboratories | Potency & Assay | Nationwide |