Hospira Recalls Morphine Sulfate Injection Due to Sterility Concerns
Hospira Inc. is recalling 26,100 vials of Morphine Sulfate Injection because a loose crimp on the vial cap may compromise sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of sterility in an injectable drug, which poses a significant risk of infection.
Plain-English summary
Hospira Inc. is recalling 26,100 vials of Preservative-Free Morphine Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL). The recall is due to a lack of assurance of sterility caused by a loose crimp applied to the fliptop vial.
The affected product is identified by Lot 15-065-DK with an expiration date of September 1, 2013. The vials were distributed nationwide and in Puerto Rico.
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions or replacement.
The recalled product
- Product
- MORPHINE SULFATE (MORPHINE SULFATE)
- Brand
- MORPHINE SULFATE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Affected units
- 26,100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 15-065-DK
- Exp 1SEP2013
Distribution
Part of a larger recall action
This product is one of 2 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · MORPHINE SULFATE
- CriticalFresenius Kabi Recalls Morphine Syringes Due to Labeling Error
FDA (Drugs) · 2026-08-26
- ModerateMorphine sulfate oral solution recalled over a carton size mismatch
FDA (Drugs) · 2025-12-17
- HighMorphine Sulfate Tablets Recalled Over Failed Dissolution Specifications
FDA (Drugs) · 2025-03-12
- SevereMorphine Sulfate Injection Recalled Due to Defective Vials
FDA (Drugs) · 2021-10-06
- ModerateLupin Recalls Morphine Sulfate Extended-Release Tablets for Impurity Failures
FDA (Drugs) · 2019-05-01
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29