Inventia Healthcare Duloxetine Capsules Recall: Capsule Shell Opens in Bottles
Inventia Healthcare recalls Duloxetine 30mg capsules that may open inside bottles, risking medication exposure. Affected batches 130/16/001 and 130/16/002.
Lower-risk recall
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30 s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
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What happened, in plain English
Inventia Healthcare is recalling Duloxetine Delayed-release Capsules 30mg bottles that may open inside the bottle, potentially exposing the medication to air and moisture. This could affect the drug's effectiveness and safety. Read more at govinfonow.com/recall/42288-inventia-healthcare-duloxetine-capsules-recall-capsule-shell-opens-in-bottles.
Source Summary by GovInfoNow · govinfonow.com/recall/42288-inventia-healthcare-duloxetine-capsules-recall-capsule-shell-opens-in-bottles · Updated October 9, 2026 · FDA enforcement record: FDA #D-0224-2017
Cite this page
“Inventia Healthcare Duloxetine Capsules Recall: Capsule Shell Opens in Bottles.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42288-inventia-healthcare-duloxetine-capsules-recall-capsule-shell-opens-in-bottles. Based on FDA recall #D-0224-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0224-2017%22&limit=1).
Why it’s dangerous
Capsule shells in these bottles may open, allowing the medication to come into contact with air and moisture. This could reduce the drug's effectiveness and potentially cause safety issues.
Who’s affected
Prescription holders of Duloxetine 30mg capsules in bottles with batch numbers 130/16/001 or 130/16/002. People using these specific batches are most at risk.
How to tell if you have this one
Check for bottles labeled 'Duloxetine Delayed-release Capsules USP 30 mg 30-count' with batch numbers 130/16/001 or 130/16/002. These were distributed by Cipia USA, Inc. in the United States.
- Brand
Inventia Healthcare- Category
Drug
What to do — step by step
Check Capsule Integrity
Inspect the bottle to see if capsules open inside the bottle. If they do, stop using the product.
How this recall unfolded
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-0224-2017 (October 19, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0224-2017 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.