Reported Apr 16, 2025 · Ongoing
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: 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 100mg/mL1mL Single-Dose VialRx Only
- Manufactured bySomerset Therapeutics Limited, Kamataka, India
- Manufactured forBluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
- Lot codes and dates
NDC 68001-581-41A240482Aexp. date 08/2026NDC 68001-581-48A240482Bexp. date 08/2026
- Amount recalled
- 23,960 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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