Somerset Therapeutics Private Limited 2025-04-16 Health serious FDA
Health · FDA · Recall #FDA-D-0356-2025
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by:… Recall
Issued April 16, 2025 · Somerset Therapeutics Private Limited
In April 2025, Somerset Therapeutics Private Limited recalled the Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by:…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility: Media fill with bacterial contamination
What you should do
- 1 Stop using Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by:… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Somerset Therapeutics Private Limited to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Somerset Therapeutics Private Limited
- Category
- Health
- Recall date
- April 16, 2025
- Units affected
- Not reported
- Sold at
- U.S. Nationwide
- Recall number
- FDA-D-0356-2025
- Made in
- India
- Issuing agency
- FDA
In context
- Somerset Therapeutics Private Limited has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.