Compounded pain injection syringes recalled over presence of particulate matter
QuVa Pharma is recalling 75,885 syringes of its R.E.C.K. periarticular injection over the presence of particulate matter.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: particulate matter in an injectable product is a hazard, and no injuries are reported.
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…
- Manufacturer
- QuVa Pharma, Inc.
- Category
- Drug — Injectable
- Affected units
- 75,885
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 (20)
- Lot
- expiry: 10149179
- exp 10/15/2025
- 10149503
- exp 10/13/2025
- 10149504
- 10149657
- exp 10/16/2025
- 10149658
- 10149659
- 10150137
- exp 10/23/2025
- 10150138
- 10150139
- 10150140
- 10149729
- 10149730
- 10149732
- 10149733
- 10149737
Distribution
Distributed nationwide across the United States.
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