Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles Recalled by Inventia Healthcare Private Limited Due to Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside...

Date: October 19, 2016
Company: Inventia Healthcare Private Limited
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Inventia Healthcare Private Limited directly.

Affected Products

Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02

Quantity: 46,848 delayed-release capsules

Why Was This Recalled?

Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s 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.

Where Was This Sold?

United States

About Inventia Healthcare Private Limited

Inventia Healthcare Private Limited has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report