CLASS II Drug recall · Reported 16 Mar 2016 · FDA Enforcement Report

Hydromorphone HCL 10 mg/ml, vol recalled by Hartley Medical Center

Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 10 mg/ml, vol, distributed nationwide in the US. The recall was initiated on 4 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBUD: 5/3/2016

Quantity recalled1 syringe

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-0752-2016
FDA event ID: 73304
Recalling firm: Hartley Medical Center Pharmacy, Long Beach, CA
Classification: Class II
Status: Terminated
Recall initiated: 4 Feb 2016
FDA classified: 4 Mar 2016
Reported: 16 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Drug class: Pain Medication

Timeline

4 Feb 2016	Recall initiated by company
4 Mar 2016	Classified by FDA	+29 days
16 Mar 2016	Published in enforcement report	+12 days

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

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Hydromorphone HCL 10 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

Where it was distributed

Nationwide. No foreign distribution.

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

BUD: 5/3/2016

Where was it sold?

Nationwide. No foreign distribution.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

29 other products · FDA event 73304

This product is part of a recall event; the main page for the event is Hydromorphone HCL 25 mg/ml, vol recalled by Hartley Medical Center.

Reported	Class	Recall	Company	Reason	Where
16 Mar 2016	CLASS II	Hydromorphone HCL 25 mg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Morphine Sulfate 0.6 mg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Baclofen 2000 mcg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Morphine Sulfate 20 mg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Morphine Sulfate 11 mg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Morphine Sulfate 1.5 mg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Hydromorphone HCL 1 mg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol., syringe recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Morphine Sulfate 9 mg/ml/Sufentanil Cit recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Fentanyl Citrate 1.275 mg/ml/Baclofen recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Hydromorphone HCL 0.5 mg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Hydromorphone HCL 2 mg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Baclofen 5000 mcg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Morphine Sulfate 10 mg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Morphine Sulfate 0.5 mg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016	CLASS II	Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide

More recalls from Hartley Medical Center Pharmacy

All 32

Reported	Class	Recall	Company	Reason	Where
16 Mar 2016Drug	CLASS II	Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016Drug	CLASS II	Morphine Sulfate 0.5 mg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016Drug	CLASS II	Morphine Sulfate 10 mg/ml, vol recalled by Hartley Medical Center	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016Drug	CLASS II	Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide
16 Mar 2016Drug	CLASS II	Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol recalled	Hartley Medical Center Pharmacy	Sterility	Nationwide

Other Hydromorphone recalls

All 155

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