Haloperidol Decanoate Injection Recalled for Sterility Assurance Defect
Somerset Therapeutics is recalling 997 vials of Haloperidol Decanoate Injection 50mg/mL nationwide due to lack of assurance of sterility following bacterial contamination detected in a media fill validation test.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II recall involving a sterile injectable drug where bacterial contamination was detected in media fill testing. Lack of assurance of sterility in injectable medications represents a serious potential health risk warranting a Severe classification, even though no illnesses have been reported.
Plain-English summary
Somerset Therapeutics Private Limited is recalling Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vials (NDC 70069-381-01 and NDC 70069-381-10, lot codes A240467A and A240467C with expiration date 07/2026) manufactured for Somerset Therapeutics, LLC, Somerset, NJ 08873. A total of 997 vials have been distributed nationwide.
The recall was initiated because a media fill validation test detected bacterial contamination, which resulted in lack of assurance of sterility for the affected product. The FDA has classified this as a Class II recall.
Haloperidol Decanoate Injection is a prescription antipsychotic medication administered by intramuscular injection. Patients currently taking this medication should not discontinue use without consulting their healthcare provider, as doing so could result in serious adverse health consequences. Healthcare providers and patients who have received or dispensed this product should contact Somerset Therapeutics or the FDA for guidance on replacement product availability and proper disposal.
Anyone with questions or concerns about this recall may contact the FDA's Drug Safety and Availability team or Somerset Therapeutics at the contact information provided on the FDA's drug recalls website.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Somerset Therapeutics Private Limited
- Hazard
- bacterial-contamination
- sterility-assurance-defect
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 70069-381-01
- A240467A
- exp. date 07/2026
- NDC 70069-381-10
- A240467C
UPCs (5)
- 0370069382011
- 0370069383018
- 0370069031018
- 0370069030011
- 0370069384015
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · HALOPERIDOL DECANOATE
- SevereHaloperidol Decanoate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2025-04-30
- SevereHaloperidol Decanoate Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2025-04-30
- SevereHaloperidol Decanoate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2025-04-30
- SevereHaloperidol Decanoate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2025-04-16
- SevereHaloperidol Decanoate Injection Recalled for Sterility Assurance Failure
FDA (Drugs) · 2025-04-16
Same category
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateClinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
FDA (Drugs) · 2026-07-22