FDA Drugs recall ·
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only… recall
- Recall number
- D-0357-2025
- Date
- (initiated March 21, 2025)
- Company / brand
- Somerset Therapeutics Private Limited
54/1 Budihal Village, Bengaluru, N/A, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 23,960 vials
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
Why was it recalled?
Lack of Assurance of Sterility: Media fill with bacterial contamination
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
NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
Distribution
U.S. Nationwide
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-0357-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.