Teva Pharmaceuticals USA, Inc.

FDA Drug Class III Ongoing

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, I

November 7, 2025 Teva Pharmaceuticals USA, Inc. 15,944 cartons units

FDA Drug Class II Ongoing

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Ma

October 13, 2025 Teva Pharmaceuticals USA, Inc. 4680 cartons units

FDA Drug Class II Ongoing

Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10

October 7, 2025 Teva Pharmaceuticals USA, Inc. 181,659 bottles units

FDA Drug Class II Ongoing

Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500

October 7, 2025 Teva Pharmaceuticals USA, Inc. 107,673 units

FDA Drug Class II Ongoing

Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10

October 7, 2025 Teva Pharmaceuticals USA, Inc. 291,512 bottles units

FDA Drug Class II Ongoing

Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2

May 23, 2025 Teva Pharmaceuticals USA, Inc. 36612 cartons units

FDA Drug Class II Ongoing

Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459

January 10, 2025 Teva Pharmaceuticals USA, Inc. 34,636 cartons units

FDA Drug Class II Ongoing

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

August 8, 2024 Teva Pharmaceuticals USA, Inc. 7,080 unit dose packets units

FDA Drug Class II Ongoing

Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc.

June 28, 2024 Teva Pharmaceuticals USA, Inc. 116,144 bottles units

FDA Drug Class II Ongoing

Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharm

June 4, 2024 Teva Pharmaceuticals USA, Inc. 34,448 bottles units

FDA Drug Class II Ongoing

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 05

March 28, 2024 Teva Pharmaceuticals USA, Inc. 5,304 3x10-cartons units

FDA Drug Class II Terminated

Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wale

March 7, 2024 Teva Pharmaceuticals USA, Inc. 92,676 cartons units

FDA Drug Class III Ongoing

Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTIC

January 25, 2024 Teva Pharmaceuticals USA, Inc. 19,824 cartons units

FDA Drug Class III Ongoing

Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., Nor

January 25, 2024 Teva Pharmaceuticals USA, Inc. 12,916 cartons units

FDA Drug Class II Ongoing

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

January 8, 2024 Teva Pharmaceuticals USA, Inc. 10,672 30-count bottles units

FDA Drug Class III Terminated

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

November 10, 2023 Teva Pharmaceuticals USA, Inc.

FDA Drug Class II Terminated

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28

July 5, 2023 Teva Pharmaceuticals USA, Inc. 180 bottles units

FDA Drug Class III Terminated

Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28

April 27, 2023 Teva Pharmaceuticals USA, Inc. 1908 units

FDA Drug Class III Terminated

Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28

April 27, 2023 Teva Pharmaceuticals USA, Inc. 438 units

FDA Drug Class III Terminated

Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28

April 27, 2023 Teva Pharmaceuticals USA, Inc. 3032 units

FDA Drug Class III Terminated

Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28

April 27, 2023 Teva Pharmaceuticals USA, Inc. 397 units

FDA Drug Class III Terminated

Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28

April 27, 2023 Teva Pharmaceuticals USA, Inc. 1272 units

FDA Drug Class III Terminated

Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet N

March 27, 2023 Teva Pharmaceuticals USA, Inc. 3,772 cartons units

FDA Drug Class II Terminated

Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tar

February 23, 2023 Teva Pharmaceuticals USA, Inc. 715,632 bottles units

FDA Drug Class II Terminated

Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc.

February 22, 2023 Teva Pharmaceuticals USA, Inc. 12,044 Bottles units

FDA Drug Class II Terminated

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bot

August 29, 2022 Teva Pharmaceuticals USA, Inc. 83,703 bottles units

FDA Drug Class II Terminated

Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01

August 23, 2022 Teva Pharmaceuticals USA, Inc.

FDA Drug Class III Terminated

Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

July 22, 2022 Teva Pharmaceuticals USA, Inc. 4162 cartons units

FDA Drug Class II Terminated

Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Act

July 21, 2022 Teva Pharmaceuticals USA, Inc. 5677 bottles units

FDA Drug Class II Terminated

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

July 21, 2022 Teva Pharmaceuticals USA, Inc. 8022 bottles units

FDA Drug Class II Terminated

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, Distribut

June 29, 2022 Teva Pharmaceuticals USA, Inc. 12354 cartons units

FDA Drug Class II Terminated

Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.

June 14, 2022 Teva Pharmaceuticals USA, Inc. 4941 bottles units

FDA Drug Class III Terminated

Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-

May 18, 2022 Teva Pharmaceuticals USA, Inc. 3109 cartons units

FDA Drug Class I Terminated

Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.

May 11, 2022 Teva Pharmaceuticals USA, Inc. 4224 cartons units

FDA Drug Class II Terminated

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Di

April 15, 2022 Teva Pharmaceuticals USA, Inc. 353964 units units

FDA Drug Class I Terminated

IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.

March 29, 2022 Teva Pharmaceuticals USA, Inc. 1565 vials units

FDA Drug Class II Terminated

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 Phar

November 4, 2019 Teva Pharmaceuticals USA, Inc. 3,623 bottles units

FDA Drug Class III Terminated

Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95.

November 14, 2013 Teva Pharmaceuticals USA, Inc. 234,242 bottles units

FDA Drug Class II Terminated

Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville,

November 8, 2013 Teva Pharmaceuticals USA, Inc. 7,020 bottles units

FDA Drug Class II Terminated

CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11

August 13, 2013 Teva Pharmaceuticals USA, Inc. 780 vials units

FDA Drug Class II Terminated

Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharma

August 6, 2013 Teva Pharmaceuticals USA, Inc. 9003 Bottles units

FDA Drug Class II Terminated

Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01

July 23, 2013 Teva Pharmaceuticals USA, Inc. 6267 bottles units

FDA Drug Class II Terminated

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01

June 18, 2013 Teva Pharmaceuticals USA, Inc. 13,478 bottles units

FDA Drug Class III Terminated

Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2

June 18, 2013 Teva Pharmaceuticals USA, Inc. 109,080 Bottles units

FDA Drug Class II Terminated

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01

June 18, 2013 Teva Pharmaceuticals USA, Inc. 16,293 bottles units

FDA Drug Class II Terminated

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01

June 18, 2013 Teva Pharmaceuticals USA, Inc. 7,579 bottles units

FDA Drug Class II Terminated

Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake

May 28, 2013 Teva Pharmaceuticals USA, Inc. 316 cartons units

FDA Drug Class III Terminated

Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)

April 26, 2013 Teva Pharmaceuticals USA, Inc. 758,554 bottles units

FDA Drug Class III Terminated

Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01

March 19, 2013 Teva Pharmaceuticals USA, Inc. 68,322 bottles units

FDA Drug Class III Terminated

Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58

March 15, 2013 Teva Pharmaceuticals USA, Inc. 36,708 blister packs units