Endo USA
NDC labeler code: 42023
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Neostigmine methylsulfate and glycopyrrolatePrevduo · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| February 23, 2023 | NDA216903 | Neostigmine methylsulfate and glycopyrrolate PREVDUO | Azurity |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
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September 8, 2026 · Class II · Ongoing · D-0876-2026 · Buprenorphine
Crystallization
Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05
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June 12, 2026 · Class II · Ongoing · D-0596-2026 · Buprenorphine
Crystallization; identified as Buprenorphine free base
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
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March 13, 2026 · Class II · Ongoing · D-0527-2026 · Buprenorphine
Crystallization; identified as Buprenorphine free base
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
2024
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January 17, 2024 · Class II · Completed · D-0342-2024 · Epinephrine
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01
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January 11, 2024 · Class II · Ongoing · D-0232-2024 · Vasopressin (vasopressin, unspecified)
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Ch
2023
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March 16, 2023 · Class III · Ongoing · D-0535-2023 · Epinephrine
Labeling; Incorrect NDC number on outer carton of product.
Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-1
2022
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April 13, 2022 · Class II · Terminated · D-1022-2022 · Epinephrine
cGMP deviations: Temperature abuse
Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple dose vial, Rx only, MFG: Par Pharma, NDC 42023-168-01
2021
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November 9, 2021 · Class II · Terminated · D-0087-2024 · Buprenorphine
Crystallization; identified as Buprenorphine free base
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-0
2019
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April 30, 2019 · Class I · Terminated · D-1293-2019 · Mycophenolate mofetil
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044
2017
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April 28, 2017 · Class II · Terminated · D-0698-2017 · Buprenorphine
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring
Show the 1 older recalls
2012
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June 5, 2012 · Class III · Terminated · D-1420-2012 · Oxytocin
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026