FDA Issues Class II Recalls for Multiple Injectable Products Due to Sterility Concerns

The US Food and Drug Administration (FDA) has announced a series of Class II recalls involving several injectable drug products manufactured by Somerset Therapeutics Private Limited due to lack of assurance of sterility stemming from bacterial contamination during media fill testing. The recalls, all initiated on March 21, 2025, affect the following products distributed nationwide:

• Haloperidol Decanoate Injection (50 mg/mL and 100 mg/mL), totaling 30 153 vials across various NDCs and lots.
• Methocarbamol Injection USP, 100 mg/mL, with a significantly larger volume of 506 080 vials impacted across multiple lots and expiration dates into mid-2026.

All recalls were classified by the FDA as Class II on April 8, 2025, indicating that exposure to the affected products may lead to temporary or medically reversible adverse health effects, but the probability of serious consequences is low. The recalling firm, Somerset Therapeutics Private Limited (Bengaluru, India), notified US distributors via letters, although no public press release was issued. The distributed products were marketed under Somerset Therapeutics LLC and BluePoint Laboratories, with packaging and labeling occurring in the US. 

Haloperidol Decanoate is a long-acting antipsychotic used for the treatment of schizophrenia and other chronic psychotic disorders. Methocarbamol Injection is a centrally acting muscle relaxant used as an adjunct therapy for acute musculoskeletal pain and muscle spasms.