Haloperidol Decanoate injection recalled due to sterility assurance failure
Somerset Therapeutics is recalling Haloperidol Decanoate Injection due to failed sterility testing. The recall affects 997 vials distributed nationwide with expiration date 07/2026.
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: This FDA Class II recall involves a sterile injectable pharmaceutical product with a confirmed manufacturing quality control failure—bacterial contamination detected in sterility testing. The recall qualifies as a risk-of-harm product for injectable use. No illnesses or injuries have been reported, limiting the score to 3 (High).
Plain-English summary
Somerset Therapeutics Private Limited is recalling Haloperidol Decanoate Injection 50mg/mL due to a failed media fill sterility assurance test that detected bacterial contamination in the manufacturing process. The recall affects 997 single-dose vials with lot numbers A240467A and A240467C (NDC 70069-381-01 and NDC 70069-381-10) with expiration date 07/2026. The affected product was distributed nationwide.
Haloperidol Decanoate is a prescription antipsychotic medication administered by intramuscular injection. The failure of the sterility assurance test indicates a breakdown in manufacturing controls that could compromise the safety of the injectable product.
Patients and healthcare providers who have this product should discontinue use of the affected product immediately. Patients should contact their healthcare provider to discuss alternative treatment options and any concerns about injections already received.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Somerset Therapeutics Private Limited
- Hazard
- bacterial-contamination
- sterility-failure
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
- HighPrescription Haloperidol Decanoate Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2025-04-30
- HighInjectable Drug Haloperidol Decanoate Recalled for Bacterial Contamination
FDA (Drugs) · 2025-04-30
- HighHaloperidol Decanoate injection recalled due to sterility assurance failure
FDA (Drugs) · 2025-04-30
- HighHaloperidol Decanoate injection recalled for sterility assurance failure
FDA (Drugs) · 2025-04-16
- HighHaloperidol Decanoate Injection Recalled Due to Bacterial Contamination Risk
FDA (Drugs) · 2025-04-16
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27