Drugs Recalls

FDA Drug Class II Ongoing

Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for I

April 15, 2025 Nubratori, Inc 20 boxes units

FDA Drug Class II Terminated

Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15

April 15, 2025 Pharmadel, LLC 20,048 bottles units

FDA Drug Class II Terminated

Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02

April 15, 2025 Pharmadel, LLC 6,048 bottles units

FDA Drug Class II Terminated

DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15

April 15, 2025 Pharmadel, LLC 27,648 bottles units

FDA Drug Class III Ongoing

HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.

April 15, 2025 OurPharma LLC 1,375 cassettes units

FDA Drug Class II Ongoing

FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct,

April 15, 2025 Apollo Care, LLC 440 bags units

FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 079

April 14, 2025 Breckenridge Pharmaceutical, Inc 16,473 bottles units

FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distribut

April 14, 2025 Breckenridge Pharmaceutical, Inc 343,344 bottles units

FDA Drug Class I Ongoing

ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.

April 14, 2025 SAINI TRADE INC 300 boxes units

FDA Drug Class I Ongoing

ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.

April 14, 2025 SAINI TRADE INC 500 boxes units

FDA Drug Class I Ongoing

Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.

April 14, 2025 SAINI TRADE INC 300 boxes units

FDA Drug Class I Ongoing

MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.

April 14, 2025 SAINI TRADE INC 500 boxes units

FDA Drug Class II Ongoing

ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61

April 14, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 133 cartons units

FDA Drug Class I Ongoing

Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.

April 14, 2025 SAINI TRADE INC 3000 boxes units

FDA Drug Class II Ongoing

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Sel

April 10, 2025 Accord Healthcare, Inc. 4,885 Bottles units

FDA Drug Class II Ongoing

Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, Ind

April 10, 2025 Eugia US LLC 36,816 vials units

FDA Drug Class II Ongoing

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Sela

April 10, 2025 Accord Healthcare, Inc. 18,984 Bottles units

FDA Drug Class II Terminated

clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 44

April 10, 2025 Lupin Pharmaceuticals Inc. 2724 bottles units

FDA Drug Class II Ongoing

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Sela

April 10, 2025 Accord Healthcare, Inc. 4,872 Bottles units

FDA Drug Class II Ongoing

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Sel

April 10, 2025 Accord Healthcare, Inc. 4,888 Bottles units

FDA Drug Class II Ongoing

Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC

April 9, 2025 Apipharma 4,218 boxes units

FDA Drug Class II Ongoing

Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by:

April 9, 2025 Cardinal Health Inc. 48 Cartons units

FDA Drug Class II Ongoing

Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West

April 9, 2025 Apipharma 5,095 cartons units

FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ

April 3, 2025 Zydus Pharmaceuticals USA Inc 3144 bottles, pack size: 100's Count units

FDA Drug Class II Ongoing

Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka,

April 2, 2025 Amerisource Health Services LLC 14,189 vials units

FDA Drug Class II Ongoing

Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, In

April 2, 2025 Amerisource Health Services LLC 143 1x5 vials units

FDA Drug Class II Ongoing

Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, M

April 2, 2025 Amerisource Health Services LLC 2,110 vials units

FDA Drug Class II Ongoing

Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11

March 31, 2025 Denver Solutions, LLC DBA Leiters Health 16,655 syringes units

FDA Drug Class II Terminated

Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY

March 31, 2025 Medisca Inc. 161.6 grams units

FDA Drug Class II Ongoing

dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131

March 31, 2025 Denver Solutions, LLC DBA Leiters Health 23,610 syringes units

FDA Drug Class II Ongoing

0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10

March 31, 2025 B. Braun Medical Inc 32,256 Bottles units

FDA Drug Class II Ongoing

Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11

March 31, 2025 Denver Solutions, LLC DBA Leiters Health 170 syringes units

FDA Drug Class II Ongoing

Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11

March 31, 2025 Denver Solutions, LLC DBA Leiters Health 49,830 syringes units

FDA Drug Class II Ongoing

PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,

March 31, 2025 Denver Solutions, LLC DBA Leiters Health 7,290 syringes units

FDA Drug Class II Ongoing

Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2

March 26, 2025 Chattem Inc 129,240 bottles units

FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Ph

March 26, 2025 Breckenridge Pharmaceutical, Inc 14,863 bottles units

FDA Drug Class II Ongoing

Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00

March 24, 2025 RemedyRepack Inc. 1,858 30-count blister cards units

FDA Drug Class II Terminated

Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 432

March 24, 2025 Amerisource Health Services LLC 889 cartons units

FDA Drug Class II Ongoing

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41

March 21, 2025 Somerset Therapeutics Private Limited 4956 vials units

FDA Drug Class II Ongoing

Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.

March 21, 2025 Zydus Pharmaceuticals USA Inc 13,128 100-Count Bottles units

FDA Drug Class II Ongoing

Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069

March 21, 2025 Somerset Therapeutics Private Limited 506,080 vials units

FDA Drug Class II Ongoing

Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10

March 21, 2025 Somerset Therapeutics Private Limited 240 vials units

FDA Drug Class II Ongoing

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x

March 21, 2025 Somerset Therapeutics Private Limited 997 vials units

FDA Drug Class II Ongoing

Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (in

March 21, 2025 Somerset Therapeutics Private Limited 23,960 vials units

FDA Drug Class II Ongoing