Actavis Pharma, Inc.

• MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 11 products
• DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 10 products
• AlprazolamXanax, Xanax XR · 8 products
• ClonidineClonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day · 7 products
• TestosteroneVogelxo, Natesto Nasal Gel, Testopel · 7 products
• LisinoprilZestril, Qbrelis · 6 products
• BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 6 products
• GuanfacineIntuniv · 6 products
• Morphine sulfateMs Contin, Mitigo, Duramorph · 6 products
• Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfateAdderall, Mixed Salts of a Single Entity Amphetamine Product XR, Adderall XR · 6 products
• IsotretinoinZenatane, Absorica, Accutane · 6 products
• Desipramine hydrochlorideNorpramin · 6 products
• Ropinirole5 products
• MetoprololToprol XL, Lopressor, Kapspargo · 4 products
• LoxapineAdasuve · 4 products
• LamotrigineLamictal, Lamictal XR, Subvenite · 4 products
• Perphenazine4 products
• Amoxapine4 products
• Propranolol hydrochlorideInderal La, Inderal XL, Hemangeol · 4 products
• Butalbital, acetaminophen and caffeineFioricet · 3 products
• Potassium citrateUrocit-K · 3 products
• TizanidineZanaflex, Ontralfy · 3 products
• DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 3 products
• Verapamil hydrochloride3 products
• DextroamphetamineZenzedi, Xelstrym, Dexedrine Spansule · 3 products
• Lisinopril and hydrochlorothiazideZestoretic · 3 products
• GabapentinNeurontin, Gralise, Relgaabi · 3 products
• DesvenlafaxinePristiq Extended-Release · 3 products
• DiclofenacZipsor, Lofena, Cambia · 3 products
• Oxazepam3 products
• Prednisone3 products
• DuloxetineDrizalma Sprinkle · 3 products
• Betamethasone dipropionateDiprolene, Sernivo · 3 products
• Estazolam2 products
• AmbrisentanLetairis · 2 products
• Tetracycline hydrochloride2 products
• DocetaxelBeizray, Docivyx · 2 products
• BuprenorphineBelbuca, Brixadi, Buprenorphine Transdermal System · 2 products
• Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 2 products
• MesalaminePentasa, Lialda, Mesalamine Rectal · 2 products
• BosentanTracleer · 2 products
• LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 2 products
• AllopurinolAloprim · 2 products
• Minoxidil2 products
• LactuloseKristalose, Lactulose Crystalline, Enulose · 2 products
• TemazepamRestoril · 2 products
• Indapamide2 products
• GlipizideGlucotrol XL · 2 products
• Dicyclomine hydrochloride2 products
• NabumetoneRelafen Ds · 2 products
• Solifenacin succinate2 products
• Memantine hydrochloride2 products
• Promethazine hydrochloridePhenergan, Promethegan · 2 products
• Isosorbide mononitrate2 products
• Diclofenac sodium and misoprostolArthrotec, Dicloenac Sodium and Misoprostol DR · 2 products
• CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 2 products
• Atenolol and chlorthalidone2 products
• Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 2 products
• HydrochlorothiazideInzirqo · 2 products
• Triamterene and hydrochlorothiazide2 products
• Nizatidine2 products
• AcyclovirZovirax, Avaclyr · 2 products
• Trihexyphenidyl hydrochloride2 products
• Sulindac2 products
• Pilocarpine hydrochlorideSalagen, Qlosi · 2 products
• Buprenorphine and naloxoneZubsolv, Buprenorphine and Naloxone Sublingual Film, Suboxone · 2 products
• Tamoxifen citrateSoltamox · 2 products
• Fluvoxamine maleate2 products
• Butalbital, acetaminophen, caffeine and codeine phosphate2 products
• RamelteonRozerem · 1 product
• AlbendazoleAlbenza · 1 product
• LevalbuterolXopenex HFA · 1 product
• PenicillamineAagylur, Depen, Cuprimine · 1 product
• PrimidoneMysoline · 1 product
• Tranylcypromine sulfateParnate · 1 product
• Vinorelbine1 product
• Azelaic acidFinacea Foam, Azelex · 1 product
• Clarithromycin1 product
• BexaroteneTargretin · 1 product
• Orphenadrine citrate1 product
• TretinoinRetin-A, Retin-A Micro, Altreno · 1 product
• NystatinNystop, Klayesta, Nyamyc · 1 product
• Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 1 product
• DesoximetasoneTopicort · 1 product
• Clindamycin phosphate and tretinoinZiana · 1 product
• Pentazocine hydrochloride and naloxone hydrochloride1 product
• Trospium chloride1 product
• VigabatrinSabril, Vigadrone, Vigafyde · 1 product
• Fluocinolone acetonideFluocinolone Acetonide Oil, Derma-Smoothe/Fs, Synalar · 1 product
• GriseofulvinUltramicrosize Griseofulvin, Griseofulvin Microsize · 1 product
• HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 1 product
• DesonideTridesilon Cream · 1 product
• Valproic acid1 product
• SildenafilViagra, Vybrique, Revatio · 1 product
• Probenecid and colchicine1 product
• Metaxalone1 product
• BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 1 product
• UrsodiolReltone 200 Mg, Ursolign, Urso Forte · 1 product
• ScopolamineScopolamine Trandermal System, Transderm Scop · 1 product
• Pimecrolimus1 product
• IvermectinStromectol, Soolantra · 1 product
• FosaprepitantFocinvez, Emend, Navitrux · 1 product
• MifepristoneKorlym · 1 product
• MiconazoleOravig · 1 product
• Doxylamine succinate and pyridoxine hydrochlorideDiclegis, Bonjesta · 1 product
• DalfampridineAmpyra · 1 product
• ValganciclovirValcyte · 1 product
• Fludarabine phosphate1 product
• AdapaleneDifferin · 1 product
• LevetiracetamKeppra, Spritam, Keppra XR · 1 product
• Ciclopirox1 product
• Chlorzoxazone1 product
• Hydroxocobalamin (hydroxocobalamin acetate)1 product
• Tranexamic acidCyklokapron · 1 product
• Minocycline hydrochlorideArestin, Zilxi, Amzeeq · 1 product
• Doxorubicin hydrochlorideDoxil, Doxorubicin Hydrochloride Liposome · 1 product
• IbuprofenIbu, Caldolor · 1 product
• Alvimopan1 product
• Probenecid1 product
• Irinotecan hydrochlorideCamptosar, Onivyde · 1 product
• TopotecanHycamtin · 1 product
• Clotrimazole and betamethasone dipropionate1 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. March 19, 2026 · Class II · Ongoing · D-0472-2026 · Clonidine

   CGMP Deviations: use of an unapproved raw material

   Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc

2. March 19, 2026 · Class II · Ongoing · D-0474-2026 · Clonidine

   CGMP Deviations: use of an unapproved raw material

   Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc

3. March 19, 2026 · Class II · Ongoing · D-0473-2026 · Clonidine

   CGMP Deviations: use of an unapproved raw material

   Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc

4. January 29, 2026 · Class II · Ongoing · D-0355-2026 · Metoprolol

   Failed Dissolution Specifications

   Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

5. January 29, 2026 · Class II · Ongoing · D-0357-2026 · Metoprolol

   Failed Dissolution Specifications

   Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11

6. January 29, 2026 · Class II · Ongoing · D-0354-2026 · Metoprolol

   Failed Dissolution Specifications

   Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

7. January 29, 2026 · Class II · Ongoing · D-0356-2026 · Metoprolol

   Failed Dissolution Specifications

   Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.

8. January 12, 2026 · Class II · Ongoing · D-0446-2026 · Isotretinoin

   Superpotent and Subpotent

   Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).

9. January 12, 2026 · Class II · Ongoing · D-0445-2026 · Isotretinoin

   Superpotent and Subpotent

   Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).

2025

1. November 7, 2025 · Class III · Ongoing · D-0198-2026 · Testosterone

   Defective Container - A defect in the side-seal which allows leakage of product.

   Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ

2024

1. August 8, 2024 · Class II · Ongoing · D-0637-2024 · Testosterone

   Superpotent Drug

   Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30

2. March 28, 2024 · Class II · Ongoing · D-0439-2024 · Isotretinoin

   Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

   Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15

3. January 8, 2024 · Class II · Ongoing · D-0275-2024 · Budesonide

   Failed Dissolution Specifications

   Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2

2023

1. November 10, 2023 · Class III · Terminated · D-0127-2024 · Testosterone

   OOS for viscosity

   Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30

2022

1. July 21, 2022 · Class II · Terminated · D-1302-2022 · Diltiazem

   Failed Dissolution Specifications: below specification limits for dissolution.

   Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsip

2. June 29, 2022 · Class II · Terminated · D-1289-2022 · Testosterone

   Superpotent Drug: Out of specification assay result was obtained during stability testing.

   Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharm

3. April 13, 2022 · Class II · Terminated · D-1067-2022 · Levalbuterol

   cGMP deviations: Temperature abuse

   Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 0591-2927-54

4. April 13, 2022 · Class II · Terminated · D-1068-2022 · Lidocaine

   cGMP deviations: Temperature abuse

   Lidocaine Patch 5%, 30-count box, Rx only, MFG: Teva Pharma USA, NDC 0591-3525-30

5. January 26, 2022 · Class II · Terminated · D-0175-2024 · Dicyclomine hydrochloride

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01

6. January 26, 2022 · Class II · Terminated · D-0191-2024 · Metoprolol

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96

7. January 18, 2022 · Class II · Terminated · D-0461-2022 · Doxylamine succinate and pyridoxine hydrochloride

   Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient

   Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Ph

2021

1. October 28, 2021 · Class III · Terminated · D-0235-2022 · Clonidine

   Failed Impurities/Degradation Specifications

   Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04

2. October 27, 2021 · Class II · Terminated · D-0232-2022 · Diltiazem

   Labelling: Incorrect Exp. Date

   Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laborat

3. March 15, 2021 · Class II · Terminated · D-0580-2021 · Levalbuterol

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

4. March 15, 2021 · Class II · Terminated · D-0581-2021 · Desvenlafaxine

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30 Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

2020

1. November 11, 2020 · Class III · Terminated · D-0100-2021 · Testosterone

   Superpotent Drug: High out-of-specification assay results were obtained during stability testing.

   Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt L

2. October 28, 2020 · Class II · Terminated · D-0069-2021 · Mesalamine

   Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.

   Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, ND

3. July 14, 2020 · Class II · Terminated · D-1492-2020 · Lidocaine

   Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.

   Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30

4. February 20, 2020 · Class II · Terminated · D-0862-2020 · Mesalamine

   Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.

   Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 059

5. January 27, 2020 · Class II · Terminated · D-0837-2020 · Methylphenidate

   CGMP deviations: Product bottle may be absent of desiccant.

   Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01

6. January 27, 2020 · Class II · Terminated · D-0836-2020 · Methylphenidate

   CGMP deviations: Product bottle may be absent of desiccant.

   Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01

2019

1. November 4, 2019 · Class II · Terminated · D-0518-2020 · Valganciclovir

   Presence of foreign substance: Brown/black particles found during stability testing.

   Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany

2. September 6, 2019 · Class III · Terminated · D-0131-2020 · Diltiazem

   GMP Deviation: lot not intended for commercial distribution.

   Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ ND

2018

1. July 5, 2018 · Class II · Terminated · D-0909-2018 · Fluocinolone acetonide

   Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.

   Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, N

2. April 30, 2018 · Class III · Terminated · D-0857-2018 · Lidocaine

   Failed Stability Specifications

   Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)

2016

1. July 11, 2016 · Class II · Terminated · D-1448-2016 · Dextroamphetamine

   Failed Dissolution Specifications

   Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 4596

2015

1. February 10, 2015 · Class II · Terminated · D-0395-2015 · Dextroamphetamine

   Failed Dissolution Specifications

   Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC

2014

1. December 15, 2014 · Class II · Terminated · D-0337-2015 · Gabapentin

   Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

   Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110,

2. December 15, 2014 · Class II · Terminated · D-0338-2015 · Gabapentin

   Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

   Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108

3. December 15, 2014 · Class II · Terminated · D-0336-2015 · Gabapentin

   Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

   Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108

4. September 26, 2014 · Class II · Terminated · D-0258-2015 · Diclofenac sodium and misoprostol

   Failed Tablet/Capsule Specifications: Presence of split or broken tablets.

   Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6.

5. April 24, 2014 · Class II · Terminated · D-1616-2014 · Diclofenac sodium and misoprostol

   Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

   Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.

6. April 24, 2014 · Class II · Terminated · D-1617-2014 · Diclofenac sodium and misoprostol

   Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

   Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.

7. February 10, 2014 · Class II · Terminated · D-1153-2014 · Alprazolam

   Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.

   Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50

2013

1. December 20, 2013 · Class II · Terminated · D-1082-2014 · Diclofenac sodium and misoprostol

   Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

   Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.

2. November 15, 2013 · Class III · Terminated · D-1043-2014 · Bupropion

   Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.

   BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laborato

3. October 9, 2013 · Class II · Terminated · D-018-2014 · Alprazolam

   Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets

   Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11

4. March 22, 2013 · Class II · Terminated · D-817-2013 · Diclofenac sodium and misoprostol

   Failed Tablet/Capsule Specifications: Broken tablets

   Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60

5. March 22, 2013 · Class II · Terminated · D-1060-2014 · Diclofenac sodium and misoprostol

   Failed Tablet/Capsule Specifications: Broken tablets

   Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)

6. February 13, 2013 · Class III · Terminated · D-190-2013 · Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

   Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.

   Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200

2012

1. April 17, 2012 · Class III · Terminated · D-1402-2012 · Loxapine

   Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

   Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01

2. April 17, 2012 · Class III · Terminated · D-1401-2012 · Loxapine

   Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

   Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01

3. April 17, 2012 · Class III · Terminated · D-1400-2012 · Loxapine

   Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

   Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01

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).

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

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