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FDA enforcement reports · negotiated drugs

Drug recalls that name Medicare negotiated drugs

FDA enforcement report entries that name a package of a drug in Medicare's negotiation program, grouped by FDA's class and newest first. An entry is a record of what the firm reported and FDA classified; it is not advice about a package you hold. Each drug's page lists its own: all negotiated drugs.

34 entriesClass I: 6Class II: 27Class III: 1Reported July 19, 2017 to May 27, 2026openFDA, read November 7, 2026

Class I

6 entries, newest first.

ReportedDrugStatusRecalling firmReason (shortened)Packages named
April 21, 2021D-0611-2021NovologTerminatedNovo Nordisk IncTemperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.6
April 21, 2021D-0612-2021NovologTerminatedNovo Nordisk IncTemperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.6
April 21, 2021D-0613-2021NovologTerminatedNovo Nordisk IncTemperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.6
April 21, 2021D-0615-2021NovologTerminatedNovo Nordisk IncTemperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.6
April 21, 2021D-0616-2021NovologTerminatedNovo Nordisk IncTemperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.6
July 19, 2017D-0959-2017EliquisTerminatedBristol-myers Squibb CompanyLabeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.1

Class II

27 entries, newest first.

ReportedDrugStatusRecalling firmReason (shortened)Packages named
May 27, 2026D-0546-2026CimziaOngoingUCB Biosciences Inc.Lack of Assurance of Sterility4
January 7, 2026D-0244-2026OzempicOngoingNovo Nordisk Inc.Presence of Particulate Matter: Hair was found in a prefilled syringe1
January 7, 2026D-0245-2026OzempicOngoingNovo Nordisk Inc.Presence of Particulate Matter: Hair was found in a prefilled syringe1
August 13, 2025D-0571-2025XolairOngoingCardinal Health Inc.CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.9
August 13, 2025D-0572-2025XolairOngoingCardinal Health Inc.CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.9
May 7, 2025D-0393-2025OzempicOngoingCardinal Health Inc.Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated...1
January 3, 2024D-0185-2024JardianceTerminatedCARDINAL HEALTHCARECGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.6
March 29, 2023D-0468-2023JardianceTerminatedBoehringer Ingelheim Pharmaceuticals, Inc.Labeling: Label Mix-up6
May 25, 2022D-0883-2022TrulicityCompletedCardinal Health Inc.TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.1
May 25, 2022D-0884-2022TrulicityCompletedCardinal Health Inc.TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions8
April 13, 2022D-0746-2022JanumetTerminatedMERCK SHARP & DOHME CORPPresence of foreign substance: Presence of stainless steel particulates in tablets.10
September 1, 2021D-0773-2021TrulicityTerminatedEli Lilly & CompanyLabeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.8
July 14, 2021D-0650-2021XolairTerminatedGenentech IncFailed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.9
June 2, 2021D-0417-2021LinzessTerminatedCardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.1
June 2, 2021D-0481-2021Trelegy ElliptaTerminatedCardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.4
June 2, 2021D-0482-2021Trelegy ElliptaTerminatedCardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.4
June 2, 2021D-0536-2021OzempicTerminatedCardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.12
May 16, 2018D-0740-2018OtezlaTerminatedKroger Specialty Pharmacy, Inc.Lack of Processing Controls.1
May 16, 2018D-0742-2018CosentyxTerminatedKroger Specialty Pharmacy, Inc.Lack of Processing Controls.1
May 16, 2018D-0746-2018EnbrelTerminatedKroger Specialty Pharmacy, Inc.Lack of Processing Controls.1
May 16, 2018D-0758-2018XolairTerminatedKroger Specialty Pharmacy, Inc.Lack of Processing Controls.1
May 16, 2018D-0762-2018StelaraTerminatedKroger Specialty Pharmacy, Inc.Lack of Processing Controls.1
May 16, 2018D-0763-2018CimziaTerminatedKroger Specialty Pharmacy, Inc.Lack of Processing Controls.1
May 16, 2018D-0768-2018PomalystTerminatedKroger Specialty Pharmacy, Inc.Lack of Processing Controls.1
May 16, 2018D-0769-2018XtandiTerminatedKroger Specialty Pharmacy, Inc.Lack of Processing Controls.1
May 16, 2018D-0777-2018IbranceTerminatedKroger Specialty Pharmacy, Inc.Lack of Processing Controls.1
May 16, 2018D-0799-2018KisqaliTerminatedKroger Specialty Pharmacy, Inc.Lack of Processing Controls.1

Class III

1 entry, newest first.

ReportedDrugStatusRecalling firmReason (shortened)Packages named
January 3, 2024D-0160-2024Anoro ElliptaTerminatedGlaxoSmithKline LLCFailed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification2

Questions

What are the recall classes?

FDA assigns each recall a class by health risk: Class I is the most serious, Class II covers a temporary or reversible risk and Class III is the least serious. The class is FDA's, not ours.

Does an entry mean a package I have is affected?

No. An entry records a recall that names a package of the drug by its NDC; it does not say which lots you hold. Check the lot against the recall notice and ask your pharmacist.

Is this every recall?

It is every entry in the openFDA enforcement file we read (November 7, 2026) that names a package of a negotiated drug by NDC. A recall that does not list NDCs, or that was reported after that file, is not here.

For developers: recent changes as data

The change feed for the last 30 days (shortage rows, program status and NADAC prices) as one file, each event with a receipt.

Example file: https://omnirx.org/api/v1/changes/last-30-days.json

The licence page sets out what a data licence covers, and the API page documents these files.

Evaluation files with receipts; contract may change; not clinical advice.

Sources and terms. openFDA drug enforcement reports, file read November 7, 2026 (openFDA data file); CC0 per the openFDA terms. Reasons are shortened where long. Library edition 2026-11. Every figure is stored with its source and date in the OmniRx library: see where every figure comes from. Not medical, legal or financial advice. Licence the data.