Glass Particulate Matter Found in Lots of Ketorolac Tromethamine

The US Food and Drug Administration (FDA) has issued a Class II recall for Ketorolac Tromethamine Injection, USP (60 mg/2 mL, 30 mg/mL) packaged in 2 mL single-dose vials for intramuscular use. The affected product was manufactured by Aspiro Pharma Limited in Telangana, India, and distributed in the US by Camber Pharmaceuticals, Inc., based in Piscataway, New Jersey. The recall involves multiple lots—AS1240347A, AS1240144A, AS1240145A, AS1240146A, and AS1250295A—with expiration dates ranging from May 2026 to May 2027. The recall was voluntarily initiated on October 1, 2025, after the identification of glass particulate matter in certain vials.

The FDA classified this recall as Class II on October 21, 2025, indicating that use of the affected product could result in temporary or medically reversible adverse health effects, though the probability of serious injury is low. The discovery of glass particulates poses potential risks such as injection site reactions, embolism, or other vascular complications if administered.

Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the short-term management of moderate to severe pain requiring analgesia at the opioid level, particularly in postoperative and musculoskeletal settings. Pharmacists should immediately inspect inventory for affected lots labeled under NDC 31722-307-25 (carton) and 31722-307-02 (vial), quarantine any impacted units, and coordinate with providers to prevent administration of compromised product.

Reference

FDA. Enforcement Report. October 22, 2025. Accessed October 23, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm