The Recall Desk
HighFDA (Drugs)·D-0357-2025·Announced 2025-04-16

[pending] HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)

Pending LLM rewrite. Source: FDA_DRUG D-0357-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Lack of Assurance of Sterility: Media fill with bacterial contamination

The recalled product

Product
HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Brand
HALOPERIDOL DECANOATE
Manufacturer
Somerset Therapeutics Private Limited

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.

Same brand · HALOPERIDOL DECANOATE