October 2025 FDA Recall Drug by Quva Pharma, Inc.
D-0113-2026 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Quva Pharma, Inc. on October 10, 2025 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0113-2026

Reason for Recall
Presence of Particulate Matter
Initiated
10-10-2025
Reported
11-05-2025
Quantity
75,885 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97790
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
QuVa Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the 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, TX 77478. NDC 70092-1433-50

Batch or Lot Expiration Information

Lot# Lot, expiry: 10149179 , exp 10/15/2025 ; 10149503 , exp 10/13/2025 ; 10149504 , exp 10/13/2025 ; 10149657 , exp 10/16/2025 ; 10149658 , exp 10/16/2025 ; 10149659 , exp 10/15/2025 ; 10150137 , exp 10/23/2025 ; 10150138 , exp 10/23/2025 ; 10150139 , exp 10/23/2025 ; 10150140 , exp 10/23/2025 ; 10149729 , exp 10/16/2025 ; 10149730 , exp 10/16/2025 ; 10149732 , exp 10/16/2025 ; 10149733 , exp 10/16/2025 ; 10149737 , exp 10/16/2025 ; 10149738 , exp 10/16/2025 ; 10149790 , exp 10/17/2025 ; 10149787 , exp 10/16/2025 ; 10149788 , exp 10/16/2025 ; 10149791 , exp 10/17/2025 ; 10149792 , exp 10/16/2025 ; 10149800 , exp 10/16/2025 ; 10149841 , exp 10/19/2025 ; 10149833 , exp 10/19/2025 ; 10149840 , exp 10/19/2025 ; 10149842 , exp 10/20/2025 ; 10149838 , exp 10/19/2025 ; 10149839 , exp 10/19/2025 ; 10149843 , exp 10/20/2025 ; 10149968 , exp 10/20/2025 ; 10149969 , exp 10/21/2025 ; 10150007 , exp 10/22/2025 ; 10150134 , exp 10/23/2025 ; 10150253 , exp 10/26/2025 ; 10150254 , exp 10/26/2025 ; 10150135 , exp 10/23/2025 ; 10150302 , exp 10/27/2025 ; 10150303 , exp 10/28/2025 ; 10150182 , exp 10/31/2025 ; 10150183 , exp 10/23/2025 ; 10150185 , exp 10/24/2025 ; 10150184 , exp 10/23/2025 ; 10150186 , exp 10/23/2025 ; 10150187 , exp 10/23/2025 ; 10150204 , exp 10/27/2025 ; 10150357 , exp 10/29/2025 ; 10150358 , exp 10/29/2025 ; 10150361 , exp 10/29/2025 ; 10150362 , exp 10/29/2025 ; 10150525 , exp 10/30/2025 ; 10150526 , exp 10/30/2025 ; 10150527 , exp 10/30/2025 ; 10150528 , exp 10/30/2025 ; 10150532 , exp 10/30/2025 ; 10150533 , exp 10/30/2025 ; 10150534 , exp 10/30/2025 ; 10150535 , exp 10/30/2025 ; 10150537 , exp 10/30/2025 ; 10150538 , exp 10/30/2025 ; 10150550 , exp 10/31/2025 ; 10150551 , exp 10/31/2025 ; 10150596 , exp 11/3/2025 ; 10150597 , exp 11/3/2025 ; 10150598 , exp 11/3/2025 ; 10150599 , exp 11/3/2025 ; 10150616 , exp 11/3/2025 ; 10150617 , exp 11/3/2025 ; 10150619 , exp 11/3/2025 ; 10150620 , exp 11/3/2025 ; 10150631 , exp 11/3/2025 ; 10150632 , exp 11/3/2025 ; 10150633 , exp 11/3/2025 ; 10150634 , exp 11/3/2025 ; 10150613 , exp 11/3/2025 ; 10150614 , exp 11/3/2025 ; 10150677 , exp 11/3/2025 ; 10150720 , exp 11/4/2025 ; 10150650 , exp 11/5/2025 ; 10150778 , exp 11/5/2025 ; 10150779 , exp 11/5/2025 ; 10150883 , exp 11/5/2025 ; 10151024 , exp 11/5/2025 ; 10151025 , exp 11/5/2025 ; 10150884 , exp 11/6/2025 ; 10151061 , exp 11/11/2025 ; 10151069 , exp 11/11/2025 ; 10150944 , exp 11/9/2025 ; 10150945 , exp 11/9/2025 ; 10151121 , exp 11/12/2025 ; 10151129 , exp 11/13/2025 ; 10150948 , exp 11/9/2025 ; 10150949 , exp 11/9/2025 ; 10151184 , exp 11/13/2025 ; 10151195 , exp 11/13/2025 ; 10150961 , exp 11/9/2025 ; 10150980 , exp 11/10/2025 ; 10150981 , exp 11/10/2025 ; 10150984 , exp 11/10/2025 ; 10150985 , exp 11/10/2025 ; 10151013 , exp 11/10/2025 ; 10151051 , exp 11/11/2025 ; 10151052 , exp 11/11/2025 ; 10151055 , exp 11/11/2025 ; 10151056 , exp 11/11/2025 ; 10151070 , exp 11/12/2025 ; 10151071 , exp 11/11/2025 ; 10151014 , exp 11/11/2025 ; 10151072 , exp 11/12/2025 ; 10151074 , exp 11/12/2025 ; 10151075 , exp 11/12/2025 ; 10151078 , exp 11/12/2025 ; 10151079 , exp 11/12/2025 ; 10151111 , exp 11/12/2025 ; 10151112 , exp 11/12/2025 ; 10151115 , exp 11/12/2025 ; 10151116 , exp 11/12/2025 ; 10151130 , exp 11/12/2025 ; 10151131 , exp 11/13/2025 ; 10151132 , exp 11/13/2025 ; 10151134 , exp 11/13/2025 ; 10151135 , exp 11/13/2025 ; 10151138 , exp 11/13/2025 ; 10151139 , exp 11/13/2025 ; 10151173 , exp 11/17/2025 ; 10151174 , exp 11/17/2025 ; 10151177 , exp 11/13/2025 ; 10151178 , exp 11/13/2025 ; 10151196 , exp 11/14/2025 ; 10151197 , exp 11/13/2025 ; 10151199 , exp 11/14/2025 ; 10151200 , exp 11/14/2025 ; 10151203 , exp 11/14/2025 ; 10151204 , exp 11/14/2025 ; 10151418 , exp 11/19/2025 ; 10151419 , exp 11/19/2025 ; 10151423 , exp 11/19/2025 ; 10151424 , exp 11/19/2025 ; 10151442 , exp 11/19/2025 ; 10151443 , exp 11/19/2025 ; 10151447 , exp 11/19/2025 ; 10151448 , exp 11/19/2025 ; 10151462 , exp 11/19/2025 ; 10151463 , exp 11/19/2025 ; 10151464 , exp 11/19/2025 ; 10151466 , exp 11/20/2025 ; 10151468 , exp 11/19/2025 ; 10151467 , exp 11/20/2025 ; 10151470 , exp 11/24/2025 ; 10151471 , exp 11/24/2025 ; 10151475 , exp 11/24/2025 ; 10151476 , exp 11/24/2025 ; 10151505 , exp 11/23/2025 ; 10151506 , exp 11/23/2025 ; 10151509 , exp 11/23/2025 ; 10151510 , exp 11/23/2025 ; 10151523 , exp 11/24/2025 ; 10151524 , exp 11/24/2025 ; 10151525 , exp 11/23/2025 ; 10151527 , exp 11/24/2025 ; 10151528 , exp 11/24/2025 ; 10151531 , exp 11/24/2025 ; 10151532 , exp 11/24/2025 ; 10151546 , exp 11/24/2025 ; 10151547 , exp 11/24/2025 ; 10151550 , exp 11/24/2025 ; 10151551 , exp 11/24/2025 ; 10151563 , exp 11/24/2025 ; 10151564 , exp 11/24/2025 ; 10151567 , exp 11/24/2025 ; 10151568 , exp 11/24/2025 ; 10151580 , exp 11/24/2025 ; 10151581 , exp 11/24/2025 ; 10151582 , exp 11/24/2025 ; 10151584 , exp 11/25/2025 ; 10151585 , exp 11/25/2025 ; 10151588 , exp 11/25/2025 ; 10151589 , exp 11/25/2025 ; 10151600 , exp 11/25/2025 ; 10151601 , exp 11/25/2025 ; 10151604 , exp 11/25/2025 ; 10151605 , exp 11/25/2025 ; 10151705 , exp 11/25/2025 ; 10151706 , exp 11/25/2025 ; 10151707 , exp 11/25/2025 ; 10151711 , exp 11/26/2025 ; 10151727 , exp 11/26/2025 ; 10151728 , exp 11/25/2025 ; 10151729 , exp 11/25/2025 ; 10151770 , exp 11/26/2025 ; 10151771 , exp 11/27/2025 ; 10151788 , exp 11/26/2025 ; 10151789 , exp 11/26/2025 ; 10151969 , exp 12/2/2025 ; 10151979 , exp 12/1/2025 ; 10151980 , exp 12/1/2025 ; 10151970 , exp 12/2/2025 ; 10151981 , exp 12/2/2025 ; 10151982 , exp 12/1/2025 ; 10151971 , exp 12/2/2025 ; 10152008 , exp 12/2/2025 ; 10152009 , exp 12/2/2025 ; 10152010 , exp 12/3/2025 ; 10152060 , exp 12/3/2025 ; 10152061 , exp 12/9/2025 ; 10152011 , exp 12/2/2025 ; 10152121 , exp 12/4/2025 ; 10152122 , exp 12/4/2025 ; 10152012 , exp 12/3/2025 ; 10152064 , exp 12/4/2025 ; 10152123 , exp 12/4/2025 ; 10152124 , exp 12/5/2025 ; 10152178 , exp 12/7/2025 ; 10152062 , exp 12/4/2025 ; 10152175 , exp 12/7/2025 ; 10152179 , exp 12/8/2025 ; 10152180 , exp 12/8/2025 ; 10152063 , exp 12/4/2025 ; 10152176 , exp 12/7/2025 ; 10152177 , exp 12/7/2025 ; 10152323 , exp 12/9/2025 ; 10152339 , exp 12/9/2025 ; 10152374 , exp 12/11/2025 ; 10152340 , exp 12/10/2025 ; 10152341 , exp 12/10/2025 ; 10152375 , exp 12/11/2025 ; 10152371 , exp 12/10/2025 ; 10152372 , exp 12/10/2025 ; 10152376 , exp 12/11/2025 ; 10152373 , exp 12/10/2025 ; 10152393 , exp 12/11/2025 ; 10152428 , exp 12/11/2025 ; 10152394 , exp 12/11/2025 ; 10152395 , exp 12/10/2025 ; 10152429 , exp 12/12/2025 ; 10152774 , exp 12/16/2025 ; 10152775 , exp 12/16/2025 ; 10152834 , exp 12/21/2025 ; 10152835 , exp 12/21/2025 ; 10152861 , exp 12/22/2025