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Class II · ModerateActive recall

Haloperidol Decanoate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberNDC [redacted-phone]; A240482A, exp. date 08/2026; NDC [redacted-phone]; A240482B, exp. date 08/2026
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility: Media fill with bacterial contamination

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySomerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories foreign manufacturer
Brand nameHALOPERIDOL DECANOATE
Generic nameHALOPERIDOL DECANOATE
Active ingredient(s)HALOPERIDOL DECANOATE
Distributed by / forBluePoint Laboratories
NDC68001-581-41
Show the full FDA record
Full product labelHaloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
Recalling firmSomerset Therapeutics Private Limited
DistributionU.S. Nationwide
Quantity23,960 vials
Recall initiated2025-03-21
Report date2025-04-16
Recall completed—
Recall numberD-0357-2025
ClassificationClass II
FDA statusOngoing
Origin on fileBengaluru N/A India

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.