CLASS II Drug recall · Reported 1 Jan 2014 · FDA Enforcement Report
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ recalled
Amedra Pharmaceuticals is recalling Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, distributed nationwide in the US. The recall was initiated on 7 Oct 2013 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-385-2014
- FDA event ID
- 66593
- Recalling firm
- Amedra Pharmaceuticals, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Oct 2013
- FDA classified
- 23 Dec 2013
- Reported
- 1 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 7 Oct 2013 | Recall initiated by company | |
| 23 Dec 2013 | Classified by FDA | +77 days |
| 1 Jan 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 Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
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
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Which lots are affected?
Lot# 243459; Exp. 01/14
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.
More recalls from Amedra Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg recalled | Amedra Pharmaceuticals | Potency & Assay | Nationwide |