Haloperidol Decanoate Injection Recalled Due to Sterility Concerns
Somerset Therapeutics is recalling Haloperidol Decanoate Injection (100 mg/mL, 1 mL vials) due to lack of assurance of sterility caused by bacterial contamination detected in media fill testing.
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: FDA Class II recall with a serious potential hazard: lack of sterility assurance in an intramuscular injection raises risk of infection and serious adverse health consequences, meeting the rubric criterion for Severe classification.
Plain-English summary
Somerset Therapeutics Private Limited is recalling Haloperidol Decanoate Injection, 100 mg/mL, 1 mL single-dose vials, due to lack of assurance of sterility. The issue was identified through media fill testing, which detected bacterial contamination in the manufacturing process.
The recalled product includes 240 vials with lot number A240482D and expiration date 08/2026, distributed nationwide in the United States. This is a prescription injectable medication manufactured for Somerset Therapeutics, LLC in Somerset, NJ.
Patients currently using this medication should consult their healthcare provider or pharmacist regarding continued use. Healthcare providers and pharmacies should stop dispensing the affected lot and contact patients who may have received this product.
The recalled product
- Product
- HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Somerset Therapeutics Private Limited
- Affected units
- 240
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 (2)
- A240482D
- exp. date 08/2026
UPCs (5)
- 0370069382011
- 0370069383018
- 0370069031018
- 0370069030011
- 0370069384015
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 →Related recalls
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