Recalls / Class II
Class IID-0254-2025
Product
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.
- Affected lot / code info
- Lot #s: a) 24220672, Exp 02/19/2025; 24280145, Exp 03/18/2025; 24240711, Exp 03/19/2025; b) 24180729, Exp 01/23/2025; 25030427, Exp 07/17/2025; c) 24360865, 24360864, Exp 03/31/2025; 24480235, Exp 06/21/2025.
Why it was recalled
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recalling firm
- Firm
- Safecor Health, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4060 Business Park Dr Ste B, Columbus, Ohio 43204-5047
Distribution
- Quantity
- 12390 Oral Syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-02-17
- FDA classified
- 2025-03-05
- Posted by FDA
- 2025-03-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0254-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.