CLASS II Drug recall · Reported 6 Mar 2013 · FDA Enforcement Report
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg recalled
Amedra Pharmaceuticals is recalling Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, distributed nationwide in the US. The recall was initiated on 4 Dec 2012 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-171-2013
- FDA event ID
- 63926
- Recalling firm
- Amedra Pharmaceuticals, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Dec 2012
- FDA classified
- 27 Feb 2013
- Reported
- 6 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 4 Dec 2012 | Recall initiated by company | |
| 27 Feb 2013 | Classified by FDA | +85 days |
| 6 Mar 2013 | Published in enforcement report | +7 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: The affected lots may not meet the specifications for dissolution over the product shelf life.
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, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Which lots are affected?
Lot 238316, exp 01/31/2014
Where was it sold?
Nationwide 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 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
2 other products · FDA event 63926This product is part of a recall event; the main page for the event is Dextroamphetamine Sulfate Extended Release Capsules, 5 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg recalled | Amedra Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS II | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg recalled | Amedra Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Amedra Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ recalled | Amedra Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg recalled | Amedra Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg recalled | Amedra Pharmaceuticals | 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 recalledDextroamphetamine Sulfate | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Tablets USP, 5 mg recalled | Impax Laboratories | Potency & Assay | Nationwide |