CLASS III Drug recall · Reported 23 Sep 2015 · FDA Enforcement Report
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg recalled
Novartis Pharmaceuticals is recalling Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, distributed in New Jersey. The recall was initiated on 28 Jul 2015 and the FDA has classified it as Class III.
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-1430-2015
- FDA event ID
- 71830
- Recalling firm
- Novartis Pharmaceuticals, Suffern, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Jul 2015
- FDA classified
- 14 Sep 2015
- Reported
- 23 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 28 Jul 2015 | Recall initiated by company | |
| 14 Sep 2015 | Classified by FDA | +48 days |
| 23 Sep 2015 | 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: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
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
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Where it was distributed
NJ - site for distributor
Questions about this recall
Is Dexmethylphenidate HCl Extended-Release, Capsules, 10mg recalled?
Yes. Novartis Pharmaceuticals recalled Dexmethylphenidate HCl Extended-Release, Capsules, 10mg on 28 Jul 2015. The recall is Class III and its status is Terminated. Recall number D-1430-2015.
Why was it recalled?
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
Which lots are affected?
Lot #: F0002, Exp 12/2016
Where was it sold?
NJ - site for distributor
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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| Drug | CLASS II | Neoral soft gelatin capsules (cyclosporine capsules recalledNeoral | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
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Other Dexmethylphenidate recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |