Actavis Recalls Dextroamphetamine Sulfate Capsules Due to Dissolution Failure
Actavis is recalling specific lots of Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, because they failed dissolution specifications.
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Failed Dissolution Specifications
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What happened, in plain English
Actavis Inc has recalled one lot of Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, in 90-count bottles. The recall was initiated because the product failed to meet dissolution specifications. This means the medication may not release or be absorbed by the body as intended. Read more at govinfonow.com/recall/42551-actavis-recalls-dextroamphetamine-sulfate-capsules-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/42551-actavis-recalls-dextroamphetamine-sulfate-capsules-due-to-dissolution-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-1448-2016
Cite this page
“Actavis Recalls Dextroamphetamine Sulfate Capsules Due to Dissolution Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42551-actavis-recalls-dextroamphetamine-sulfate-capsules-due-to-dissolution-failure. Based on FDA recall #D-1448-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1448-2016%22&limit=1).
Why it’s dangerous
The capsules failed dissolution specifications, which is a quality control test ensuring the drug releases at the correct rate. If the drug does not dissolve properly, patients might receive less medication than prescribed, potentially leading to inadequate treatment of their condition.
Who’s affected
Patients who have been prescribed Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, by Actavis. Specifically, individuals who purchased the recalled lot may have received medication that does not perform as expected.
How to tell if you have this one
Check your bottle for NDC 45963-304-09 and Lot # 3803J141 with an expiration date of 7/2016. The product is Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, in 90-count bottles.
- Brand
Actavis- Category
Drug
What to do — step by step
Check your medication
Verify if your bottle matches NDC 45963-304-09 and Lot # 3803J141 with an expiration date of 7/2016.
Contact your pharmacy or doctor
If you have the recalled product, contact your healthcare provider or pharmacist for instructions on what to do next.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-1448-2016 (July 11, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1448-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.