Aurobindo Venlafaxine Capsules Recall: Punctured or Clumped Capsules
Aurobindo Pharma USA recalls 37.5 mg Venlafaxine Hydrochloride extended release capsules due to punctured or clumped capsules that could affect safety. This Rx-only product was manufactured for Aurobindo.
Lower-risk recall
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Contact the company
What happened, in plain English
Aurobindo Pharma USA is recalling 37.5 mg Venlafaxine Hydrochloride extended release capsules (30-count bottles) because some bottles contain punctured or clumped/melted capsules. This could lead to improper medication release and potential safety issues for users. Read more at govinfonow.com/recall/42107-aurobindo-venlafaxine-capsules-recall-punctured-or-clumped-capsules.
Source Summary by GovInfoNow · govinfonow.com/recall/42107-aurobindo-venlafaxine-capsules-recall-punctured-or-clumped-capsules · Updated October 8, 2026 · FDA enforcement record: FDA #D-0474-2017
Cite this page
“Aurobindo Venlafaxine Capsules Recall: Punctured or Clumped Capsules.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42107-aurobindo-venlafaxine-capsules-recall-punctured-or-clumped-capsules. Based on FDA recall #D-0474-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0474-2017%22&limit=1).
Why it’s dangerous
The capsules may be punctured or clumped/melted, which could cause the medication to release too quickly or not work properly. This might lead to ineffective treatment or unintended side effects.
Who’s affected
People with a prescription for Venlafaxine Hydrochloride extended release capsules (37.5 mg, 30-count bottles) from Aurobindo Pharma USA. Those who have the product and are taking it as directed are most at risk.
How to tell if you have this one
Check for bottles labeled 'Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count' with the manufacturer Aurobindo Pharma USA. The product was manufactured for Aurobindo Pharma USA, Inc. in Dayton, NJ, and has NDC 65862-527-30.
- Brand
Aurobindo- Category
Drug
What to do — step by step
Check Product
Look for bottles with the NDC code 65862-527-30 and lot number VI3716010-A.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years 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-0474-2017 (December 22, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0474-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.