FDA Drugs recall ·
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial… recall
- Recall number
- D-0367-2025
- Date
- (initiated April 2, 2025)
- Company / brand
- Amerisource Health Services LLC
2550 John Glenn Ave Ste A, Columbus, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,110 vials
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.
Why was it recalled?
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
A240467B, EXP 07/31/2026
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0367-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.