Class II — Potential Health Hazard

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

Ondansetron HCI API Recalled by Cadila Pharmaceuticals Limited Due to Microbial Contamination of Non-Sterile Product

Date: September 9, 2016
Company: Cadila Pharmaceuticals 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 Cadila Pharmaceuticals Limited directly.

Affected Products

Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002

Quantity: 6.0kg

Why Was This Recalled?

Microbial Contamination of Non-Sterile Product

Where Was This Sold?

According to the firm, the API distributed to two consignees in the US. See Consignee list below. Consignee List: 1). LLC LENS Phanna. Russia 2). Claris irljectable, Ahmedabad 3). CPL. Inc, USA

About Cadila Pharmaceuticals Limited

Cadila Pharmaceuticals 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