Allergan, Inc.
NDC labeler codes: 0023, 0430, 0456, 11980, 57970, 58914, 61874
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
- CariprazineVraylar · 6 products
- Memantine and donepezilMemantine and Donepezil Hydrochlorides Extended-Release, Namzaric · 4 products
- Levomilnacipran hydrochlorideFetzima · 4 products
- NebivololBystolic · 4 products
- IncobotulinumtoxinaXeomin, Botox, Dysport · 4 products
- Milnacipran hydrochlorideSavella · 4 products
- Risedronate sodium (risedronate sodium hemipentahydrate / risedronate sodium monohydrate)Actonel, Atelvia · 3 products
- CitalopramCelexa · 3 products
- Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 3 products
- LinaclotideLinzess · 3 products
- BimatoprostLumigan, Latisse, Durysta · 3 products
- AsenapineSaphris, Secuado · 3 products
- Vilazodone hydrochlorideViibryd · 3 products
- EscitalopramLexapro · 3 products
- FluorometholoneFml, Fml Forte · 2 products
- Prednisolone acetatePred Forte, Pred Mild · 2 products
- CyclosporineSandimmune, Neoral, Cyclosporine Modified · 2 products
- ProgesteroneCrinone, Prometrium, Endometrin · 2 products
- UbrogepantUbrelvy · 2 products
- Brimonidine tartrateAlphagan P, Mirvaso · 2 products
- EluxadolineViberzi · 2 products
- Ceftaroline fosamilTeflaro · 2 products
- UrsodiolReltone 200 Mg, Ursolign, Urso Forte · 2 products
- SucralfateCarafate · 2 products
- OfloxacinOcuflox · 1 product
- PodofiloxCondylox · 1 product
- NitroglycerinNitrostat, Nitro-Dur, Nitroglycerin in Dextrose · 1 product
- EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 1 product
- Iron dextranInfed · 1 product
- DexamethasoneTaperdex 6-Day, Hemady, Taperdex 12-Day · 1 product
- GatifloxacinZymaxid · 1 product
- AlcaftadineLastacaft · 1 product
- DalbavancinDalvance · 1 product
- OxybutyninOxytrol · 1 product
- Ceftazidime, avibactamAvycaz · 1 product
- MesalaminePentasa, Lialda, Mesalamine Rectal · 1 product
- LevonorgestrelKyleena, Skyla, Mirena · 1 product
- Brimonidine tartrate and timolol maleateCombigan · 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 22 applications
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
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May 18, 2026 · Class III · Ongoing · D-0551-2026 · Prednisolone acetate
Failed Stability Specifications
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.
2021
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March 15, 2021 · Class II · Terminated · D-0419-2021 · Nitroglycerin
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 3524
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March 15, 2021 · Class II · Terminated · D-0418-2021 · Memantine and donepezil
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC.
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March 15, 2021 · Class II · Terminated · D-0417-2021 · Linaclotide
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612
2019
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March 19, 2019 · Class II · Terminated · D-1056-2019 · Brimonidine tartrate and timolol maleate
cGMP Deviations
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05
2018
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December 20, 2018 · Class II · Completed · D-0387-2019 · Dexamethasone
GMP Deviations: A silicone particulate was noted in Ozurdex.
OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07
2017
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October 19, 2017 · Class III · Terminated · D-0078-2018 · Bimatoprost
Failed Impurities/Degradation Specifications.
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
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October 19, 2017 · Class III · Terminated · D-0077-2018 · Brimonidine tartrate and timolol maleate
Failed Impurities/Degradation Specifications.
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bot
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May 18, 2017 · Class II · Terminated · D-0880-2017 · Asenapine
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmac
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March 16, 2017 · Class III · Terminated · D-0667-2017 · Bimatoprost
Failed Impurities/Degradation Specifications
Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08.
Show the 3 older recalls
2014
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September 26, 2014 · Class II · Terminated · D-0036-2015 · Nebivolol
Failed Dissolution Specification; at the 6-month stability time point
Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07
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June 19, 2014 · Class II · Terminated · D-1412-2014 · Nebivolol
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.
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May 12, 2014 · Class II · Terminated · D-1348-2014 · Nebivolol
Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.
Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laborato
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