Zydus BuPropion XL 300mg Tablets Recall: Failed Dissolution Test
Zydus Pharmaceuticals USA recalls 500-count BuPropion XL 300mg tablets due to failed dissolution testing. This may affect medication effectiveness. Check NDC 68382-354-05 and lot number MR3365 for affected products.
Lower-risk recall
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Contact the company
What happened, in plain English
Zydus Pharmaceuticals USA is recalling 500-count bottles of BuPropion Hydrochloride Extended-Release Tablets (300 mg) because the product failed dissolution testing at an intermediate time point. This could mean the medication doesn't work as intended, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/42503-zydus-bupropion-xl-300mg-tablets-recall-failed-dissolution-test.
Source Summary by GovInfoNow · govinfonow.com/recall/42503-zydus-bupropion-xl-300mg-tablets-recall-failed-dissolution-test · Updated October 9, 2026 · FDA enforcement record: FDA #D-0149-2017
Cite this page
“Zydus BuPropion XL 300mg Tablets Recall: Failed Dissolution Test.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42503-zydus-bupropion-xl-300mg-tablets-recall-failed-dissolution-test. Based on FDA recall #D-0149-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0149-2017%22&limit=1).
Why it’s dangerous
The tablets failed to dissolve properly at an intermediate time point during testing. This could mean the medication isn't releasing the active ingredient at the right rate, potentially reducing its effectiveness. However, the recall does not indicate immediate safety risks like injury or death.
Who’s affected
People with prescriptions for BuPropion XL 300mg tablets who received bottles manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, with NDC 68382-354-05 and lot number MR3365. Those using the medication for conditions like depression or anxiety are most at risk of ineffective treatment.
How to tell if you have this one
Check for bottles labeled 'BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count' with NDC 68382-354-05 and lot number MR3365. These were distributed by Zydus Pharmaceuticals USA in the US.
- Brand
Zydus- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 68382-354-05 and lot number MR3365 on the bottle label.
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 23 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-0149-2017 (August 3, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0149-2017 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.