CLASS II Drug recall · Reported 16 Aug 2017 · FDA Enforcement Report
Hydromorphone Hydrochloride Injection, USP, 50 mg recalled
Hospira Inc Lake Forest is recalling Hydromorphone Hydrochloride Injection, USP, 50 mg/ (10 mg/mL) Single Dose Vial.(10 vials, distributed nationwide in the US. The recall was initiated on 26 Jul 2017 and the FDA has classified it as Class II.
Check your package
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-1082-2017
- FDA event ID
- 77836
- Recalling firm
- Hospira Inc Lake Forest, LAKE FOREST, IL
- Manufacturer
- Teva Parenteral Medicines, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jul 2017
- FDA classified
- 9 Aug 2017
- Reported
- 16 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 26 Jul 2017 | Recall initiated by company | |
| 9 Aug 2017 | Classified by FDA | +14 days |
| 16 Aug 2017 | 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
Presence of Particulate Matter: Silicone oil
Product as listed by the FDA
Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Silicone oil
Which lots are affected?
Lot #: 560103F, Exp. 01AUG2017
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 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
2 other products · FDA event 77836This product is part of a recall event; the main page for the event is Hydromorphone Hydrochloride Injection, USP, 500 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hydromorphone Hydrochloride Injection, USP, 500 mg recalledHydromorphone Hydrochloride | Hospira Inc Lake Forest | Particulate Matter | Nationwide | |
| CLASS II | Hydromorphone Hydrochloride Injection, USP, 500 mg recalledHydromorphone Hydrochloride | Hospira Inc Lake Forest | Particulate Matter | Nationwide |
More recalls from Hospira Inc Lake Forest
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Naloxone Hydrochloride Injection, USP, 0.4 mg/mL recalledNaloxone Hydrochloride | Hospira Inc Lake Forest | Particulate Matter | Nationwide |
| Drug | CLASS II | Hydromorphone Hydrochloride Injection, USP, 500 mg recalledHydromorphone Hydrochloride | Hospira Inc Lake Forest | Particulate Matter | Nationwide |
| Drug | CLASS II | Hydromorphone Hydrochloride Injection, USP, 500 mg recalledHydromorphone Hydrochloride | Hospira Inc Lake Forest | Particulate Matter | Nationwide |
Other Hydromorphone recalls
All 155| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | HYDROmorphone Hydrochloride 50mg/ (1mg/mL) recalled by OurPharma | OurPharma | Potency & Assay | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 30 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 25 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 20 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |