QuVa Pharma, Inc. R.e.c.k. in Sodium Chloride Solution, Total Volume: 50 mL syringe recall: Presence of Particulate Matter
Presence of Particulate Matter
The hazard: Sterility or particulate concern
This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.
What the notice says: Presence of Particulate Matter
Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.
Symptoms and when to call a doctor
Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.
This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.
Recall details
- Recall number
- D-0113-2026
- Published
- November 5, 2025
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- QuVa Pharma, Inc.
- Product type
- Prescription & OTC drugs
- Units affected
- 75,885 syringes
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- 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 ,…
Products covered by this recall
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
Check your product
The notice names 22 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Best-by / use-by date
Printed beside the lot code, not on the price sticker.
- 10149179
- exp 10
- 15
- 2025
- 10
- 13
- 16
- 23
- 17
- 19
- 20
- 21
- 22
- 26
- 27
- 28
- 31
- 24
- 29
- 30
NDC number
On the carton and again on the bottle or blister label.
- 70092-1433-50
Package size
Match the net weight or the piece count on the front of the pack.
- 50 mL
Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Sterility
QuVa Pharma, Inc. — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.
- Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
- Report any infection or reaction you think the product caused to FDA MedWatch.
- Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
- Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
Refunds and replacements
With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.
- Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
- For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
- If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
- If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.
Company contact: QuVa Pharma, Inc. — 1075 W Park One Dr Ste 100, Sugar Land, TX, 77478-2576
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was QuVa Pharma, Inc. prescription & otc drugs recalled?
Presence of Particulate Matter Presence of Particulate Matter
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: best-by date 10149179 or exp 10. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
Can I get my money back?
Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
Where was the recalled product sold?
It was distributed nationwide.
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