CLASS I Drug recall · Reported 21 Mar 2018 · FDA Enforcement Report

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL recalled

Pfizer is recalling Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, distributed nationwide in the US. The recall was initiated on 7 Feb 2018 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLots # 691853F, EXP. 9/1/2018; 700753F, EXP. 10/1/2018.

NDC0703-0018, 0703-0110, 0703-0113

UPC0307030110038

Quantity recalled53600 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0596-2018
FDA event ID: 79114
Recalling firm: Pfizer, New York, NY
Brand: Hydromorphone Hydrochloride
Manufacturer: Teva Parenteral Medicines, Inc.
Classification: Class I
Status: Terminated
Recall initiated: 7 Feb 2018
FDA classified: 14 Mar 2018
Reported: 21 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Drug class: Pain Medication

Timeline

7 Feb 2018	Recall initiated by company
14 Mar 2018	Classified by FDA	+35 days
21 Mar 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lots # 691853F, EXP. 9/1/2018; 700753F, EXP. 10/1/2018.

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 79114

This product is part of a recall event; the main page for the event is Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL recalled.

Reported	Class	Recall	Company	Reason	Where
21 Mar 2018	CLASS I	Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL recalledHydromorphone Hydrochloride	Pfizer	Foreign Material	Nationwide

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Reported	Class	Recall	Company	Reason	Where
30 Apr 2025Drug	CLASS III	HYDROmorphone Hydrochloride 50mg/ (1mg/mL) recalled by OurPharma	OurPharma	Potency & Assay	Nationwide
3 Apr 2024Drug	CLASS II	HYDROmorphone HCl 30 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	HYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	HYDROmorphone HCl 25 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	HYDROmorphone HCl 20 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide