The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0357-2025·Announced 2025-04-16

Haloperidol Decanoate Injection Recalled for Sterility Assurance Failure

Somerset Therapeutics is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility resulting from bacterial contamination detected during media fill testing. The recall affects 23,960 vials distributed nationwide.

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: The FDA classified this as a Class II recall. The hazard involves lack of assurance of sterility due to confirmed bacterial contamination detected during media fill testing of a parenteral injection product. Sterility failures in injectable drugs pose a direct risk of serious infection, meeting the Severe criteria for Class II recalls with significant potential for patient harm.

Plain-English summary

Somerset Therapeutics Private Limited is recalling Haloperidol Decanoate Injection 100 mg/mL, 1 mL single-dose vials (NDC 68001-581-41 and NDC 68001-581-48, lot numbers A240482A and A240482B, expiration date 08/2026) manufactured for BluePoint Laboratories. The recall was initiated due to lack of assurance of sterility following the detection of bacterial contamination during media fill testing.

Approximately 23,960 vials have been distributed nationwide. This is a prescription injectable medication administered intramuscularly and used in treatment of certain psychiatric conditions. The contamination detected during manufacturing process validation raises concerns about the sterile integrity of affected units.

Patients currently using this medication should consult their healthcare provider or pharmacist immediately. Do not discontinue use without medical guidance, as abrupt discontinuation of this medication may have serious health consequences. Healthcare providers should verify whether their inventory contains affected lot numbers A240482A or A240482B with expiration date 08/2026 and follow appropriate handling instructions.

The recalled product

Product
HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Brand
HALOPERIDOL DECANOATE
Manufacturer
Somerset Therapeutics Private Limited
Category
Drug — Injectable / Parenteral
Hazard
Affected units
23,960

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 (5)

  • NDC 68001-581-41
  • A240482A
  • exp. date 08/2026
  • NDC 68001-581-48
  • A240482B

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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