Haloperidol Decanoate Injection recall: Sterility Concern
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC…
Why was Haloperidol Decanoate Injection recalled?
Lack of Assurance of Sterility: Media fill with bacterial contamination
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
A240482D, exp. date 08/2026
- Product
- Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC…
- Recalling firm
- Somerset Therapeutics Private Limited
- Quantity
- 240 vials
- Distribution
- U.S. Nationwide
- Recall date
- April 16, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)