Reported Apr 16, 2025 · Ongoing
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics,…
Somerset Therapeutics Private Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Somerset Therapeutics Private Limited · 54/1 Budihal Village · Bengaluru, N/A · N/A
Is this the product you have?
- Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only
- Manufactured forSomerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10
- Lot codes and dates
A240482Dexp. date 08/2026
- Amount recalled
- 240 vials
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Media fill with bacterial contamination
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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