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Home Prescription medicine Somerset Therapeutics Private Limited —…

Food & drug recall · FDAMarch 21, 2025Serious

Somerset Therapeutics Private Limited — Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Lack of Assurance of Sterility: Media fill with bacterial contamination

The Recall Registry rates this seriousFDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Somerset Therapeutics Private Limited

The product

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)

Details

Units affected
997 vials
Recall date
March 21, 2025
Brand
Somerset Therapeutics Private Limited
Model, lot or SKU numbers
NDC 70069-381-01A240467A, exp. date 07/2026NDC 70069-381-10A240467C, exp. date 07/2026
Where it was distributed

U.S. Nationwide

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: Somerset Therapeutics Private Limited — Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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