Bausch Health US, LLC
NDC labeler codes: 0187, 13548, 16781, 25010, 66490, 99207
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
- DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 20 products
- TretinoinRetin-A, Retin-A Micro, Altreno · 12 products
- BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 5 products
- Enalapril maleateVasotec, Epaned · 4 products
- LorazepamAtivan, Loreev XR · 3 products
- ImiquimodZyclara · 3 products
- Pyridostigmine bromideMestinon, Pryidostigmine Bromide, Regonol · 3 products
- FlucytosineAncobon · 2 products
- FamotidinePepcid · 2 products
- BexaroteneTargretin · 2 products
- PrimidoneMysoline · 2 products
- Clindamycin phosphate and benzoyl peroxideOnexton, Acanya, Neuac · 2 products
- AcyclovirZovirax, Avaclyr · 2 products
- LuliconazoleLuzu · 1 product
- Halobetasol propionateBryhali, Lexette, Ultravate · 1 product
- Tetracaine hydrochloride1 product
- MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 1 product
- BrodalumabSiliq · 1 product
- MetyrosineDemser · 1 product
- TazaroteneTazorac, Fabior, Arazlo · 1 product
- Acyclovir and hydrocortisoneXerese · 1 product
- Verteporfin for injectionVisudyne · 1 product
- Clindamycin phosphate and tretinoinZiana · 1 product
- CarbidopaLodosyn · 1 product
- SelegilineEmsam, Zelapar · 1 product
- TolcaponeTasmar · 1 product
- FluorouracilFavlyxa, Tolak, Efudex · 1 product
- ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 1 product
- Clindamycin phosphate/benzoyl peroxide/adapaleneCabtreo · 1 product
- Enalapril maleate and hydrochlorothiazideVaseretic · 1 product
- Sulfacetamide sodiumKlaron · 1 product
- Ethacrynic acidEdecrin · 1 product
- PenicillamineAagylur, Depen, Cuprimine · 1 product
- Halobetasol propionate and tazaroteneDuobrii · 1 product
- Chlordiazepoxide hydrochloride and clidinium bromideLibrax · 1 product
- EfinaconazoleJublia · 1 product
- TrientineSyprine, Cuvrior · 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.
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
February 12, 2024 · Class II · Terminated · D-0347-2024 · Clindamycin phosphate/benzoyl peroxide/adapalene
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807
2019
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January 30, 2019 · Class III · Terminated · D-0488-2019 · Diltiazem
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewa
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January 30, 2019 · Class III · Terminated · D-0487-2019 · Diltiazem
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewa
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January 30, 2019 · Class III · Terminated · D-0489-2019 · Diltiazem
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottles (NDC 0187-0797-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewa
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January 30, 2019 · Class III · Terminated · D-0490-2019 · Diltiazem
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottles (NDC 0187-0798-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewa
2015
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April 18, 2015 · Class III · Terminated · D-1034-2016 · Chlordiazepoxide hydrochloride and clidinium bromide
Failed Impurities/Degradation Specifications
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for:
2014
-
May 21, 2014 · Class III · Terminated · D-0018-2015 · Enalapril maleate and hydrochlorothiazide
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada
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May 21, 2014 · Class III · Terminated · D-0019-2015 · Enalapril maleate
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-
2013
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September 20, 2013 · Class III · Terminated · D-020-2014 · Clindamycin phosphate and benzoyl peroxide
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.
Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx Only, Sample - not for sale, CORIA Laboratories, a division of Valeant Pharmaceuticals LLC, Bridgewater, NJ 08807 --- NDC 13548-132
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).
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