CLASS II Drug recall · Reported 27 Apr 2016 · FDA Enforcement Report
Dextroamphetamine Sulfate Tablets USP, 5 mg recalled
Impax Laboratories is recalling Dextroamphetamine Sulfate Tablets USP, 5 mg, distributed nationwide in the US. The recall was initiated on 14 Mar 2016 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-0826-2016
- FDA event ID
- 73679
- Recalling firm
- Impax Laboratories, Middlesex, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Mar 2016
- FDA classified
- 21 Apr 2016
- Reported
- 27 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 14 Mar 2016 | Recall initiated by company | |
| 21 Apr 2016 | Classified by FDA | +38 days |
| 27 Apr 2016 | 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
Failed Impurities/Degradation 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 Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
Where it was distributed
Nationwide
Questions about this recall
Is Dextroamphetamine Sulfate Tablets USP, 5 mg recalled?
Yes. Impax Laboratories recalled Dextroamphetamine Sulfate Tablets USP, 5 mg on 14 Mar 2016. The recall is Class II and its status is Terminated. Recall number D-0826-2016.
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #: 112565, Exp 03/17; 113458, Exp 08/17
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 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.
More recalls from Impax Laboratories
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Lamotrigine Orally Disintegrating Tablets (ODT) recalled | Impax Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Tablets USP, 10 mg recalled | Impax Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Fenofibrate Capsules (Micronized) 200 mg recalled by Impax Laboratories | Impax Laboratories | Other | Nationwide |
| Drug | CLASS III | Fenofibrate Capsules (Micronized) 134 mg recalled by Impax Laboratories | Impax Laboratories | Other | Nationwide |
Other Dextroamphetamine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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, 10 mg recalled | Impax Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg recalledDextroamphetamine Sulfate | Actavis Elizabeth | Potency & Assay | Nationwide |