Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Hydromorphone Recalled by Pfizer Inc. Due to Non-Sterility: Confirmed customer complaints of glass product container...

Date: February 7, 2018
Company: Pfizer 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 Pfizer Inc. directly.

Affected Products

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01

Quantity: 53600 vials

Why Was This Recalled?

Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pfizer Inc.

Pfizer Inc. has 114 total recalls tracked by RecallDetector.

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