Compounded pain injection syringes recalled over presence of particulate matter

Plain-English summary

R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl and Ketorolac Tromethamine) in Sodium Chloride Solution, in 50 mL syringes for periarticular use and not for intravenous use, compounded by QuVa Pharma, is being recalled over the presence of particulate matter.

The recall covers 75,885 syringes across lots including 10149179 (expired 15 October 2025), 10149503 and 10149504 (both expired 13 October 2025) and 10149657. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.

This is a compounded drug injected around a joint, so particulate matter would be introduced into tissue. The enforcement record describes the particulate and reports no injuries.

Facilities holding an affected lot should quarantine it and follow QuVa Pharma's instructions.

The recalled product

Product

R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land,

Manufacturer

QuVa Pharma, Inc.

Category

Drug — Injectable

Hazard

• particulate-matter
• compounded
• injectable

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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