QuVa Pharma Recalls Multiple Lots of R.E.C.K. Injection Over Particulate Matter Contamination

Key Clinical Summary

• Product recall: Multiple lots of R.E.C.K. (ropivacaine HCl, epinephrine, clonidine HCl, and ketorolac tromethamine) compounded injection recalled due to particulate matter.
• Recall scope: 75 885 syringes distributed nationwide for periarticular use; voluntary Class II recall initiated by QuVa Pharma.
• Clinical impact: Potential for local irritation, inflammation, or embolic events if particulates enter tissue or circulation.

QuVa Pharma, Inc. has initiated a Class II recall of multiple lots of its compounded product R.E.C.K.—a periarticular injection combining ropivacaine HCl, epinephrine, clonidine HCl, and ketorolac tromethamine in sodium chloride solution. The product is supplied in 50 mL syringes (NDC 70092-1433-50) labeled for periarticular use only and not intended for intravenous administration. The recall involves at least seven affected lots (e.g., 10149179, 10149503–10150137) with expiration dates in October 2025.

The recall, voluntarily initiated by QuVa Pharma on October 10, 2025, was prompted by the presence of particulate matter detected during internal testing. On October 27, 2025, the US Food and Drug Administration (FDA) classified the recall as Class II, indicating that exposure to the affected product could cause temporary or medically reversible adverse effects. The presence of particulates in injectable formulations poses risks such as localized inflammation, granuloma formation, or tissue damage. If inadvertently introduced into the bloodstream, particulates could potentially lead to vascular occlusion or embolic complications.

According to FDA records, the recalled product was distributed nationwide across the United States. Consignees were notified directly by letter, and no public press release has been issued to date. The recall remains ongoing, and there are no current reports of patient harm linked to the affected lots. QuVa Pharma, based in Sugar Land, Texas, has emphasized its commitment to patient safety and quality assurance as it works with the FDA to manage the recall.

R.E.C.K. is a compounded multimodal periarticular injection designed for use in orthopedic surgical settings, particularly for pain management following joint replacement or repair procedures. The combination of ropivacaine (a local anesthetic), epinephrine (to prolong anesthesia and reduce bleeding), clonidine (an alpha-2 agonist providing analgesic synergy), and ketorolac (a nonsteroidal anti-inflammatory agent) aims to reduce postoperative pain and opioid requirements.

Reference

FDA. Enforcement Report. November 5, 2025. Accessed November 5, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm