Premier Pharmacy Labs Recalls Morphine Sulfate Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling specific lots of Morphine Sulfate Injection because routine testing of other lots detected microbial contamination risks.
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 potential microbial contamination of a sterile injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Premier Pharmacy Labs Inc is recalling 4,555 syringes of Morphine Sulfate 2 mg/mL PF Injection. The affected product is distributed nationwide in the USA and is identified by NDC 69623-129-10. The specific lots involved are MOR030518IJDSA, MOR030518IJDSB, MOR030518IJDSC, MOR030518IJDSD, and MOR030518IJDSE, all with a beyond-use date of 06/03/2018.
The recall was initiated due to a lack of assurance of sterility. Microbial contamination was detected during routine testing of subsequent unreleased product lots. This issue was attributed to an interaction between the product syringe and the tamper-evident container closure, which may result in the potential introduction of microorganisms into the products.
Consumers and healthcare providers should check their inventory for the specific lot numbers and beyond-use date listed above. If the product matches these details, it should be discontinued and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable
- Affected units
- 4,555
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 (5)
- Lots: MOR030518IJDSA
- MOR030518IJDSB
- MOR030518IJDSC
- MOR030518IJDSD
- MOR030518IJDSE BUD: 06/03/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Premier Pharmacy Labs 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 4 products in this recall →Related recalls
Same manufacturer · Premier Pharmacy Labs Inc
See all →- SeverePremier Pharmacy Labs Recalls Isoproterenol HCL Bags Due to Sterility Concerns
FDA (Drugs) · 2019-07-03
- SeverePremier Pharmacy Labs Recalls Succinylcholine Chloride Syringes for Sterility Concerns
FDA (Drugs) · 2019-07-03
- SeverePremier Pharmacy Labs Recalls Phenylephrine Injection Due to Sterility Concerns
FDA (Drugs) · 2019-07-03
- SeverePremier Pharmacy Labs Recalls Droperidol Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-07-03
- SeverePremier Pharmacy Labs Recalls Orphenadrine Citrate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-07-03
Same hazard · microbial contamination
See all →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15