The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0356-2025·Announced 2025-04-16

Haloperidol Decanoate Injection Recalled for Sterility Assurance Failure

Somerset Therapeutics is recalling Haloperidol Decanoate Injection 50mg/mL vials nationwide due to lack of assurance of sterility from bacterial contamination detected in media fill testing.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving an injectable drug with a confirmed sterility assurance failure from bacterial contamination detected in manufacturing process validation. Sterility defects in injectable products pose significant risk of serious adverse health consequences including infection and sepsis, meeting the Severe criteria.

Plain-English summary

Somerset Therapeutics Private Limited is recalling Haloperidol Decanoate Injection 50mg/mL, 1mL single-dose vials (NDC 68001-580-41 and related package NDCs) manufactured in Karnataka, India and distributed by BluePoint Laboratories. The recall affects 4,956 vials distributed nationwide.

The recall was initiated because media fill testing detected bacterial contamination, which raises concerns about the lack of assurance of sterility for the affected vials. Media fill tests are performed to validate the sterility of the manufacturing process for injectable drugs. The affected vials carry lot number A240467B with an expiration date of 07/2026.

Haloperidol Decanoate is an intramuscular injection used in psychiatric treatment. Patients currently taking this medication should consult their healthcare provider or pharmacist immediately to determine if they have affected vials and discuss appropriate alternatives.

Consumers and healthcare providers should stop using affected vials and return them to the pharmacy or manufacturer. Reports of adverse events related to this recall may be submitted to the FDA at 1-888-SAFEFDA or online at www.fda.gov/medwatch.

The recalled product

Product
HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Brand
HALOPERIDOL DECANOATE
Manufacturer
Somerset Therapeutics Private Limited
Category
Drug — Injectable / Psychiatric Medication
Hazard
Affected units
4,956

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • A240467B
  • exp. date 07/2026

UPCs (4)

  • 0368001578592
  • 0368001581417
  • 0368001579599
  • 0368001582414

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Somerset Therapeutics Private Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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