Amerisource Health Services Recalls BuProlin XL 300mg Tablets Due to Dissolution Failure
Amerisource Health Services recalls 300mg BuProlin XL tablets (NDC 68001-264-03) manufactured by Cadila Healthcare due to failed dissolution testing during stability checks. No remedy specified in recall notice.
Lower-risk recall
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Contact the company
What happened, in plain English
Amerisource Health Services is recalling 300mg BuProlin XL extended-release tablets (500-count bottles) that failed dissolution testing during stability checks. This recall affects prescription-only products made by Cadila Healthcare in India. The issue could lead to inconsistent drug release, but no specific harm has been reported. Read more at govinfonow.com/recall/42496-amerisource-health-services-recalls-buprolin-xl-300mg-tablets-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/42496-amerisource-health-services-recalls-buprolin-xl-300mg-tablets-due-to · Updated October 9, 2026 · FDA enforcement record: FDA #D-1501-2016
Cite this page
“Amerisource Health Services Recalls BuProlin XL 300mg Tablets Due to Dissolution Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42496-amerisource-health-services-recalls-buprolin-xl-300mg-tablets-due-to. Based on FDA recall #D-1501-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1501-2016%22&limit=1).
Why it’s dangerous
The tablets failed dissolution testing during 3-month stability checks, meaning they may not release the medication properly over time. This could cause inconsistent drug levels in the body, but the recall does not mention any injuries or serious health effects.
Who’s affected
Prescription patients who received the specific 300mg BuProlin XL tablets (NDC 68001-264-03) manufactured by Cadila Healthcare Ltd. in Ahmedabad, India. Patients with a prescription for this medication are most at risk.
How to tell if you have this one
Check if you have a 300mg BuProlin XL tablet bottle labeled 'NDC 68001-264-03' manufactured by Cadila Healthcare Ltd. in Ahmedabad, India. The product was sold with lot number MS1509 and expired December 2017.
- Brand
Amerisource Health Services- Category
Drug
What to do — step by step
Check Product Details
Verify if your bottle has the NDC 68001-264-03 label and was manufactured by Cadila Healthcare Ltd. in Ahmedabad, India.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 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-1501-2016 (August 4, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1501-2016 to see it in context.
- Plain-language summary written by qwen3:4b 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.