fentaNYL 2500 mcg/250 mL
Medicine recall D-0553-2020. Published in FDA’s Enforcement Report on Dec 11, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 11, 2019. Copied from openFDA on Oct 20, 2026.
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots: 10029202 Exp. 11/17/2019, 10029753 Exp. 11/17/2019, 10029756 Exp. 11/17/2019, 10029792 Exp. 11/18/2019, 10029793 Exp. 11/18/2019, 10029808 Exp. 11/18/2019, 10029809 Exp. 11/18/2019, 10029810 Exp. 11/18/2019, 10029757 Exp. 11/17/2019,…
Every code shown here, 1,998 characters
Lots: 10029202 Exp. 11/17/2019, 10029753 Exp. 11/17/2019, 10029756 Exp. 11/17/2019, 10029792 Exp. 11/18/2019, 10029793 Exp. 11/18/2019, 10029808 Exp. 11/18/2019, 10029809 Exp. 11/18/2019, 10029810 Exp. 11/18/2019, 10029757 Exp. 11/17/2019, 10029758 Exp. 11/17/2019, 10029809 Exp. 11/18/2019, 10029810 Exp. 11/18/2019, 10029920 Exp. 11/19/2019, 10029897 Exp. 11/20/2019, 10029793 Exp. 11/18/2019, 10029920 Exp. 11/19/2019, 10030394 Exp. 11/25/2019, 10030395 Exp. 11/25/2019, 10030479 Exp. 11/27/2019, 10030480 Exp. 11/27/2019, 10030481 Exp. 11/27/2019, 10030449 Exp. 11/26/2019, 10030450 Exp. 11/26/2019, 10030451 Exp. 11/26/2019, 10030883 Exp. 12/2/2019, 10030885 Exp. 12/2/2019, 10030507 Exp. 11/27/2019, 10030508 Exp. 11/27/2019, 10030936 Exp. 12/3/2019, 10030937 Exp. 12/3/2019, 10030956 Exp. 12/3/2019, 10030903 Exp. 11/30/2019, 10030904 Exp. 11/30/2019, 10030988 Exp. 12/4/2019, 10030938 Exp. 12/3/2019, 10030955 Exp. 12/3/2019, 10030884 Exp. 11/30/2019, 10030902 Exp. 11/30/2019, 10030986 Exp. 12/4/2019, 10030987 Exp. 12/4/2019, 10031009 Exp. 12/4/2019, 10031127 Exp. 12/8/2019, 10031128 Exp. 12/8/2019, 10031150 Exp. 12/8/2019, 10031009 Exp. 12/4/2019, 10030506 Exp. 11/27/2019, 10030448 Exp. 11/26/2019, 10031176 Exp. 12/9/2019, 10031385 Exp. 12/9/2019, 10031127 Exp. 12/8/2019, 10031128 Exp. 12/8/2019, 10031149 Exp. 12/8/2019, 10031234 Exp. 12/10/2019, 10031235 Exp. 12/10/2019, 10031259 Exp. 12/10/2019, 10031261 Exp. 12/10/2019, 10031177 Exp. 12/9/2019, 10031384 Exp. 12/9/2019, 10030426 Exp. 11/26/2019, 10030427 Exp. 11/26/2019, 10031260 Exp. 12/10/2019, 10030957 Exp. 12/3/2019, 10031389 Exp. 12/11/2019, 10030957 Exp. 12/3/2019, 10030904 Exp. 11/30/2019, 10031502 Exp. 12/17/2019, 10031474 Exp. 12/16/2019, 10031503 Exp. 12/17/2019, 10031589 Exp. 12/19/2019, 10031611 Exp. 12/19/2019, 10031565 Exp. 12/18/2019, 10031502 Exp. 12/17/2019, 10031563 Exp. 12/17/2019, 10031693 Exp. 12/22/2019, 10031694 Exp. 12/22/2019, 10031730 Exp. 12/22/2019, 10031588 Exp. 12/19/2019, 10031589 Exp.…
FDA’s list runs to 3,112 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Barcodes and drug codes
-
NDC
70092-1093-37
As FDA’s description and codes give them; the UPCs written as digits only.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 12, 2019.
- FDA classified it on Dec 3, 2019.
- FDA’s Enforcement Report published it on Dec 11, 2019.
- FDA terminated it on Jun 5, 2020.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- QuVa Pharma, Inc., of Sugar Land, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,112 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Drug recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.