Class II — Potential Health Hazard

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

Valganciclovir Hydrochloride for Oral Solution Recalled by Teva Pharmaceuticals USA, Inc. Due to Presence of foreign substance: Brown/black particles found during...

Date: November 4, 2019
Company: Teva Pharmaceuticals USA, Inc.
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 Teva Pharmaceuticals USA, Inc. directly.

Affected Products

Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-2579-20

Quantity: 3,623 bottles

Why Was This Recalled?

Presence of foreign substance: Brown/black particles found during stability testing.

Where Was This Sold?

Product was distributed to wholesalers/distributors throughout the United States.

About Teva Pharmaceuticals USA, Inc.

Teva Pharmaceuticals USA, Inc. has 33 total recalls tracked by RecallDetector.

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