AbbVie Inc.
NDC labeler codes: 0032, 0074
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
- LevothyroxineTirosint, Tirosint Sol, Synthroid · 12 products
- PancrelipaseCreon, Zenpep, Pancreaze · 10 products
- Divalproex sodiumDepakote, Depakote ER, Depakote Sprinkles · 6 products
- Risankizumab-rzaaSkyrizi · 6 products
- ParicalcitolZemplar · 4 products
- UpadacitinibRinvoq · 4 products
- TavapadonJuvmo · 4 products
- VenetoclaxVenclexta · 3 products
- Lopinavir and ritonavirKaletra · 3 products
- AtogepantQulipta · 3 products
- RitonavirNorvir · 2 products
- ElagolixOrilissa · 2 products
- Glecaprevir and pibrentasvirMavyret · 2 products
- SevofluraneUltane, Sevoflurane, (Volatile for Inhalation), Sojourn · 2 products
- Telisotuzumab vedotinEmrelis · 2 products
- CyclosporineSandimmune, Neoral, Cyclosporine Modified · 2 products
- BeractantSurvanta · 1 product
- Carbidopa and levodopaCrexont, Rytary, Sinemet · 1 product
- Foscarbidopa/foslevodopaVyalev · 1 product
- Aztreonam and avibactamEmblaveo · 1 product
- Pivekimab sunirine-pvzyDecnupaz · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Show the other 4 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| June 7, 1995 | NDA020478 | Sevoflurane ULTANE | Abbvie |
| July 1, 1991 | BLA020032 | Beractant SURVANTA | Abbvie |
| September 12, 1989 | NDA019680 | Divalproex sodium DEPAKOTE | Abbvie |
| March 10, 1983 | NDA018723 | Divalproex sodium DEPAKOTE | Abbvie |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2023
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October 17, 2023 · Class III · Ongoing · D-0088-2024 · Levothyroxine
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
2021
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March 15, 2021 · Class II · Terminated · D-0404-2021 · Ritonavir
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A.
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March 15, 2021 · Class II · Terminated · D-0403-2021 · Elagolix
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack conta
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March 15, 2021 · Class II · Terminated · D-0402-2021 · Pancrelipase
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A.
2018
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January 22, 2018 · Class III · Terminated · D-0412-2018 · Sevoflurane
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
2017
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January 13, 2017 · Class II · Terminated · D-0495-2017 · Carbidopa and levodopa
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., North Chicago, IL 60064 --- NDC 0074-3012-07
2016
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March 24, 2016 · Class III · Terminated · D-0833-2016 · Paricalcitol
Failed Content Uniformity Specifications
Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.
2014
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September 15, 2014 · Class II · Terminated · D-1611-2014 · Pancrelipase
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07.
2012
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December 4, 2012 · Class II · Terminated · D-107-2013 · Levothyroxine
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.
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July 19, 2012 · Class II · Terminated · D-1695-2012 · Levothyroxine
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.
Show the 3 older recalls
2012
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July 19, 2012 · Class II · Terminated · D-1696-2012 · Levothyroxine
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90
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July 19, 2012 · Class II · Terminated · D-1694-2012 · Levothyroxine
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.
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May 14, 2012 · Class II · Terminated · D-1388-2012 · Paricalcitol
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05
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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- All prescription drugs A to ZSearch by generic, brand or Spanish name
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