Sandoz Dexmethylphenidate 10mg Recall: Dissolution Failure
Sandoz recalls 10,767 bottles of Dexmethylphenidate HCl Extended-Release Capsules due to failed dissolution specifications. Check your lot number.
Use caution until it’s fixed
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.
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What happened, in plain English
Sandoz Inc. is recalling one lot of Dexmethylphenidate HCl Extended-Release Capsules, 10mg, because the drug did not dissolve properly during stability testing. This means the medication may not release its active ingredient at the intended rate, potentially affecting how well it works for patients. The recall involves 10,767 bottles distributed from New Jersey. Read more at govinfonow.com/recall/43885-novartis-pharmaceuticals-corp-recalls-dexmethylphenidate-hcl-extended-release-capsules-10mg.
Source Summary by GovInfoNow · govinfonow.com/recall/43885-novartis-pharmaceuticals-corp-recalls-dexmethylphenidate-hcl-extended-release-capsules-10mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-1430-2015
Cite this page
“Sandoz Dexmethylphenidate 10mg Recall: Dissolution Failure.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43885-novartis-pharmaceuticals-corp-recalls-dexmethylphenidate-hcl-extended-release-capsules-10mg. Based on FDA recall #D-1430-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1430-2015%22&limit=1).
Why it’s dangerous
The product failed dissolution specifications at the 6-hour time point during testing. This defect means the extended-release mechanism may not function as designed, leading to unpredictable drug absorption and potentially reduced therapeutic effect for conditions like ADHD.
Who’s affected
Patients currently taking Dexmethylphenidate HCl Extended-Release Capsules, 10mg, who purchased the specific recalled lot. Individuals with this prescription should check their bottle against the recall details.
How to tell if you have this one
Look for Dexmethylphenidate HCl Extended-Release Capsules, 10mg, Rx only, in bottles of 100. The specific recalled lot number is F0002 with an expiration date of 12/2016. Manufactured by Alkermes Gainesville LLC for Sandoz Inc.
- Brand
Sandoz- Category
Drug
What to do — step by step
Check your medication bottle
Verify if your Dexmethylphenidate HCl Capsules match the recalled lot number F0002 and expiration date 12/2016.
Contact your pharmacist or doctor
If you have the recalled product, speak with your healthcare provider about alternative treatment options since no specific remedy is listed in the record.
Where it went and when
Where it was distributed
Distributed in New Jersey.
FDA distribution: “NJ - site for distributor” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Jersey.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1430-2015 (July 28, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1430-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.