fentaNYL 1000 mcg/100 mL
Medicine recall D-0555-2020. 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 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots: 10029286 Exp. 11/14/2019 10029287 Exp. 11/14/2019 10029761 Exp. 11/14/2019 10029764 Exp. 11/14/2019 10029754 Exp. 11/17/2019 10029787 Exp. 11/17/2019 10029862 Exp. 11/18/2019 10029892 Exp. 11/20/2019 10029893 Exp. 11/20/2019 10030011…
Every code shown here, 1,997 characters
Lots: 10029286 Exp. 11/14/2019 10029287 Exp. 11/14/2019 10029761 Exp. 11/14/2019 10029764 Exp. 11/14/2019 10029754 Exp. 11/17/2019 10029787 Exp. 11/17/2019 10029862 Exp. 11/18/2019 10029892 Exp. 11/20/2019 10029893 Exp. 11/20/2019 10030011 Exp. 11/24/2019 10030012 Exp. 11/24/2019 10030018 Exp. 11/24/2019 10029947 Exp. 11/21/2019 10029951 Exp. 11/21/2019 10030011 Exp. 11/24/2019 10030012 Exp. 11/24/2019 10030018 Exp. 11/24/2019 10030346 Exp. 11/24/2019 10030345 Exp. 11/24/2019 10030880 Exp. 12/2/2019 10030882 Exp. 12/2/2019 10030983 Exp. 12/4/2019 10030985 Exp. 12/4/2019 10030933 Exp. 12/3/2019 10030934 Exp. 12/3/2019 10030935 Exp. 12/3/2019 10030881 Exp. 12/2/2019 10030982 Exp. 12/4/2019 10030983 Exp. 12/4/2019 10030984 Exp. 12/4/2019 10030985 Exp. 12/4/2019 10031035 Exp. 12/5/2019 10031036 Exp. 12/5/2019 10031037 Exp. 12/5/2019 10031038 Exp. 12/5/2019 10031175 Exp. 12/9/2019 10031198 Exp. 12/10/2019 10031199 Exp. 12/10/2019 10031232 Exp. 12/10/2019 10031242 Exp. 12/10/2019 10031386 Exp. 12/10/2019 10031174 Exp. 12/9/2019 10030424 Exp. 11/26/2019 10030425 Exp. 11/26/2019 10031233 Exp. 12/10/2019 10031459 Exp. 12/16/2019 10031526 Exp. 12/16/2019 10031410 Exp. 12/15/2019 10031431 Exp. 12/15/2019 10031458 Exp. 12/16/2019 10031459 Exp. 12/16/2019 10031525 Exp. 12/16/2019 10031526 Exp. 12/16/2019 10031608 Exp. 12/19/2019 10031664 Exp. 12/20/2019 10031608 Exp. 12/19/2019 10031609 Exp. 12/19/2019 10031663 Exp. 12/20/2019 10031411 Exp. 12/15/2019 10031840 Exp. 12/24/2019 10031863 Exp. 12/24/2019 10031754 Exp. 12/26/2019 10031755 Exp. 12/26/2019 10031943 Exp. 12/26/2019 10031945 Exp. 12/26/2019 10032002 Exp. 12/27/2019 10032003 Exp. 12/27/2019 10032005 Exp. 12/27/2019 10032031 Exp. 12/27/2019 10032033 Exp. 12/27/2019 10032035 Exp. 12/27/2019 10031754 Exp. 12/26/2019 10031755 Exp. 12/26/2019 10031756 Exp. 12/26/2019 10031940 Exp. 12/26/2019 10031941 Exp. 12/26/2019 10031943 Exp. 12/26/2019 10031944 Exp. 12/26/2019 10031945 Exp. 12/26/2019 10032005 Exp. 12/27/2019 10032032…
FDA’s list runs to 2,650 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
70092-1092-36
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 2,650 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.