Drugs Recalls

17,415 recalls in this category

FDA Drug Class III Completed

Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16

January 7, 2025 PAI Holdings, LLC. dba Pharmaceutical Associates Inc 4080 Bottles units
FDA Drug Class II Ongoing

Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-42

January 7, 2025 Amerisource Health Services LLC 4640 units units
FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

December 30, 2024 Rising Pharma Holding, Inc. 42,527 bottles units
FDA Drug Class II Ongoing

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

December 30, 2024 Rising Pharma Holding, Inc. 244,460 bottles units
FDA Drug Class II Terminated

Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceutica

December 30, 2024 Granules Pharmaceuticals Inc 6,804 bottles units
FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

December 30, 2024 Rising Pharma Holding, Inc. 73,680 bottles units
FDA Drug Class II Ongoing

Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10

December 27, 2024 Eugia US LLC 17,300 10-mL vials units
FDA Drug Class II Ongoing

First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6

December 23, 2024 First Aid Beauty Ltd 2756 jars units
FDA Drug Class I Ongoing

Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.

December 23, 2024 Astellas Pharma US Inc 14,340 100-count bottles units
FDA Drug Class II Terminated

Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93

December 23, 2024 Viatris Inc 1,215/30 count bottles units
FDA Drug Class II Terminated

Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93

December 23, 2024 Viatris Inc 6,605/30 count bottles units
FDA Drug Class I Ongoing

Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.

December 23, 2024 Astellas Pharma US Inc 3,500 30-count bottles units
FDA Drug Class II Terminated

Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pit

December 20, 2024 Lupin Pharmaceuticals Inc. 480 1000-count bottles units
FDA Drug Class I Ongoing

Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01

December 20, 2024 Endo USA, Inc. 44,397 amber glass vials units
FDA Drug Class III Ongoing

Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20

December 19, 2024 West-Ward Columbus Inc 2591 100-count boxes units
FDA Drug Class II Terminated

ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office

December 19, 2024 Hikma Injectables USA Inc 1,800 syringes units
FDA Drug Class II Terminated

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

December 19, 2024 Hikma Injectables USA Inc
FDA Drug Class III Ongoing

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15

December 18, 2024 AvKARE
FDA Drug Class II Terminated

Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03

December 18, 2024 Granules Pharmaceuticals Inc 96 Bottles units
FDA Drug Class III Ongoing

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.

December 18, 2024 AvKARE 16,677 cartons units
FDA Drug Class I Ongoing

Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134

December 18, 2024 Alcon Research LLC 55,960 25-count boxes units
FDA Drug Class II Ongoing

medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acet

December 18, 2024 Eugia US LLC 19872 vials units
FDA Drug Class II Completed

glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60

December 17, 2024 Amerisource Health Services LLC 2,028 units (cartons of 30 individual unit doses) units
FDA Drug Class II Ongoing

Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC

December 16, 2024 FDC Limited 136,181 bottles units
FDA Drug Class I Ongoing

FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7

December 16, 2024 SHOPPERS- PLAZA 172 180-count bottles units
FDA Drug Class III Terminated

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01

December 16, 2024 SOMERSET THERAPEUTICS LLC 5,870 bottles units
FDA Drug Class II Ongoing

Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-42

December 13, 2024 Amerisource Health Services LLC 5,178 cartons units
FDA Drug Class II Ongoing

Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60

December 12, 2024 Ascend Laboratories LLC 10,444 bottles units
FDA Drug Class II Ongoing

Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60

December 12, 2024 Ascend Laboratories LLC 1971 bottles units
FDA Drug Class III Ongoing

Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.

December 12, 2024 Akron Pharma, Inc. 14825 bottles units
FDA Drug Class III Ongoing

Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.

December 12, 2024 Akron Pharma, Inc. 456 bottles units
FDA Drug Class III Ongoing

Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.

December 12, 2024 Akron Pharma, Inc. 324 bottles units
FDA Drug Class I Ongoing

Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia.

December 12, 2024 Buy-Herbal 26 bottles units
FDA Drug Class III Ongoing

Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .

December 12, 2024 Akron Pharma, Inc. 6429 bottles units
FDA Drug Class III Ongoing

Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.

December 12, 2024 Akron Pharma, Inc. 7198 bottles units
FDA Drug Class III Ongoing

Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.

December 12, 2024 Akron Pharma, Inc. 768 bottles units
FDA Drug Class III Ongoing

Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02

December 12, 2024 Akron Pharma, Inc. 1232 bottles units
FDA Drug Class I Ongoing

FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles

December 12, 2024 GNMart LLC 374 bottles units
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01

December 11, 2024 Glenmark Pharmaceuticals Inc., USA 3,888 units
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

December 11, 2024 Glenmark Pharmaceuticals Inc., USA
FDA Drug Class II Terminated

LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-0

December 10, 2024 Regenerative Processing Plant, LLC 170812 bottles units
FDA Drug Class II Terminated

PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82

December 10, 2024 Regenerative Processing Plant, LLC 59275 units
FDA Drug Class II Ongoing

Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless p

December 10, 2024 VIONA PHARMACEUTICALS INC 2760 packs units
FDA Drug Class II Ongoing

Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless

December 10, 2024 VIONA PHARMACEUTICALS INC 23304 packs units
FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08

December 6, 2024 Amerisource Health Services LLC 1,815 bottles units
FDA Drug Class II Ongoing

Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30

December 6, 2024 Aurobindo Pharma USA Inc
FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceu

December 6, 2024 Breckenridge Pharmaceutical, Inc 163,883 bottles units
FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05

December 6, 2024 Amerisource Health Services LLC 13,678 bottles units
FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04

December 6, 2024 Amerisource Health Services LLC 21,262 bottles units
FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04

December 6, 2024 Amerisource Health Services LLC 20,734 30-count bottles units

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