Amneal Pharmaceuticals of New York LLC

• MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 9 products
• LamotrigineLamictal, Lamictal XR, Subvenite · 8 products
• Oxymorphone hydrochloride7 products
• Dexmethylphenidate hydrochlorideFocalin XR, Focalin · 7 products
• Morphine sulfateMs Contin, Mitigo, Duramorph · 7 products
• Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfateAdderall, Mixed Salts of a Single Entity Amphetamine Product XR, Adderall XR · 6 products
• IbuprofenIbu, Caldolor · 6 products
• Valsartan and hydrochlorothiazideDiovan Hct · 5 products
• Lurasidone hydrochlorideLatuda · 5 products
• Alendronate sodiumBinosto, Fosamax · 5 products
• CarvedilolCoreg, Coreg CR · 4 products
• ValsartanDiovan · 4 products
• Hydrocodone bitartrate and ibuprofen4 products
• Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 4 products
• Benazepril hydrochlorideLotensin · 4 products
• Acitretin4 products
• Bethanechol chloride4 products
• LacosamideVimpat, Motpoly XR · 4 products
• Dipyridamole3 products
• EscitalopramLexapro · 3 products
• Colestipol hydrochlorideColestid · 3 products
• DextroamphetamineZenzedi, Xelstrym, Dexedrine Spansule · 3 products
• GabapentinNeurontin, Gralise, Relgaabi · 3 products
• BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 3 products
• NaproxenNaprelan, Rugby All Day Relief · 3 products
• Telmisartan3 products
• Dantrolene sodiumRevonto, Dantrium, Ryanodex Dantrolene Sodium · 3 products
• LevalbuterolXopenex HFA · 3 products
• Metformin hydrochlorideGlumetza · 3 products
• HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 3 products
• SpironolactoneAldactone · 3 products
• Flecainide acetate3 products
• Promethazine hydrochloridePhenergan, Promethegan · 3 products
• ApixabanEliquis, Eliquis Sprinkle · 2 products
• Terbutaline sulfate2 products
• BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 2 products
• Alosetron hydrochlorideLotronex · 2 products
• Ranitidine2 products
• Acebutolol hydrochloride2 products
• GriseofulvinUltramicrosize Griseofulvin, Griseofulvin Microsize · 2 products
• FenofibrateAntara, Lipofen, Tricor · 2 products
• PrimidoneMysoline · 2 products
• EpinephrineAuvi-Q, Adrenalin, Adrenalin (Epinephrine in Sodium Chloride) · 2 products
• Hydroxyzine2 products
• Hydrocodone bitartrate and acetaminophenNorco · 2 products
• Memantine hydrochloride2 products
• Meclizine hydrochloride2 products
• TemazepamRestoril · 2 products
• GuanfacineIntuniv · 2 products
• Fenofibric acid2 products
• Demeclocycline2 products
• FelbamateFelbatol · 2 products
• Nitrofurantoin2 products
• Chloroquine phosphate2 products
• Sulfamethoxazole and trimethoprimSulfamethoxazole and Trimethoprim Ds, Sulfatrim, Bactrim Ds · 2 products
• Colesevelam hydrochloride2 products
• Oxycodone and acetaminophenEndocet, Prolate, Percocet · 2 products
• Sevelamer carbonateRenvela · 2 products
• Pyridostigmine bromideMestinon, Pryidostigmine Bromide, Regonol · 2 products
• Metaxalone2 products
• MethyltestosteroneMethitest · 2 products
• DigoxinLanoxin · 2 products
• Folic acidQuiofic · 1 product
• Tamsulosin hydrochloride1 product
• Calcium acetate1 product
• EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 1 product
• Butalbital, aspirin, caffeine and codeine phosphateAscomp with Codeine · 1 product
• Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 1 product
• SildenafilViagra, Vybrique, Revatio · 1 product
• Fludrocortisone acetate1 product
• AlbendazoleAlbenza · 1 product
• Tramadol hydrochloride and acetaminophen1 product
• Ciprofloxacin and dexamethasone1 product
• Oxycodone hydrochlorideOxycontin, Roxybond, Roxicodone · 1 product
• Cyproheptadine1 product
• Rimantadine hydrochloride1 product
• Clindamycin palmitate hydrochlorideClindamycin Palmitate Hydrochloride (Pediatric), Cleocin Pediatric · 1 product

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

The sponsor is the company that holds the FDA application; it can differ from the labeler.

2026

1. June 3, 2026 · Class III · Ongoing · D-0585-2026 · Primidone

   Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

   Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater,

2019

1. November 22, 2019 · Class II · Ongoing · D-0616-2020 · Ranitidine

   CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

   Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

2. November 22, 2019 · Class II · Ongoing · D-0615-2020 · Ranitidine

   CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

   Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

2011

1. September 27, 2011 · Class II · Terminated · D-1450-2014 · Sulfamethoxazole and trimethoprim

   Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg

   Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Cent

1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →