Drugs Recalls
17,415 recalls in this category
FDA Drug
Class II
Ongoing
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Va
September 24, 2024
Nivagen Pharmaceuticals Inc
2328 bottles units
FDA Drug
Class II
Ongoing
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millbur
September 23, 2024
Advanced Accelerator Applications USA, Inc.
99 doses units
FDA Drug
Class I
Terminated
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2
September 19, 2024
Gilead Sciences, Inc.
105,000 vials units
FDA Drug
Class I
Ongoing
Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.
September 18, 2024
123Herbals
unknown units
FDA Drug
Class II
Ongoing
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
September 18, 2024
EnviroServe Chemicals Inc.
120 bottles units
FDA Drug
Class I
Terminated
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
September 17, 2024
Bionpharma Inc.
1,980 bottles units
FDA Drug
Class II
Ongoing
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 3002303
September 16, 2024
AbbVie Inc.
763,426 tubes units
FDA Drug
Class II
Ongoing
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
September 16, 2024
AbbVie Inc.
2,473,563 tubes units
FDA Drug
Class II
Terminated
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
September 11, 2024
Mckesson Medical-Surgical Inc. Corporate Office
27 bottles units
FDA Drug
Class II
Terminated
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Di
September 11, 2024
Mckesson Medical-Surgical Inc. Corporate Office
5 cartons/20 units each carton units
FDA Drug
Class II
Ongoing
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made
September 11, 2024
Zhejiang Jingwei Pharmaceutical Co., Ltd.
295,164 tubes units
FDA Drug
Class II
Terminated
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041
September 5, 2024
Empower Pharmacy
450 units
FDA Drug
Class II
Ongoing
Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Cha
September 3, 2024
Vivier Pharma, Inc.
3476 units units
FDA Drug
Class II
Ongoing
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, N
September 3, 2024
Ascend Laboratories LLC
117,493 bottles units
FDA Drug
Class II
Completed
Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430,
August 30, 2024
Glenmark Pharmaceuticals Inc., USA
2,031,480 ointments units
FDA Drug
Class II
Ongoing
BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4
August 28, 2024
PREQUEL SKIN
30,946 tubes units
FDA Drug
Class III
Ongoing
AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
August 24, 2024
Rubicon Research Private Limited
3,984 bottles units
FDA Drug
Class II
Ongoing
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
August 22, 2024
ProRx LLC
1,960 vials units
FDA Drug
Class II
Ongoing
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
August 22, 2024
ProRx LLC
1,489 vials units
FDA Drug
Class II
Ongoing
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
August 22, 2024
ProRx LLC
1,732 vials units
FDA Drug
Class II
Ongoing
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
August 22, 2024
ProRx LLC
500 vials units
FDA Drug
Class II
Ongoing
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
August 22, 2024
ProRx LLC
2,490 vials units
FDA Drug
Class II
Ongoing
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
August 22, 2024
ProRx LLC
37 vials units
FDA Drug
Class II
Ongoing
SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
August 22, 2024
ProRx LLC
8,396 vials units
FDA Drug
Class II
Terminated
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA,
August 21, 2024
Lupin Pharmaceuticals Inc.
4554 bottles units
FDA Drug
Class III
Terminated
Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach,
August 20, 2024
Elevate Oral Care
FDA Drug
Class II
Ongoing
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.
August 15, 2024
Fagron Compounding Services
FDA Drug
Class III
Terminated
Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibl
August 15, 2024
Biocompatibles U.K., Ltd.
432 administration packs units
FDA Drug
Class II
Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Di
August 12, 2024
FDC Limited
176,784 bottles units
FDA Drug
Class II
Ongoing
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport,
August 9, 2024
Direct Rx
1410 bottles units
FDA Drug
Class II
Ongoing
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
August 8, 2024
Preferred Pharmaceuticals, Inc
266 bottles 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 III
Completed
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawth
August 7, 2024
Taro Pharmaceuticals U.S.A., Inc.
96 vials units
FDA Drug
Class II
Ongoing
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablet
August 6, 2024
Dr. Reddy's Laboratories, Inc.
31,802 bottles units
FDA Drug
Class II
Ongoing
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tab
August 6, 2024
Dr. Reddy's Laboratories, Inc.
14940 bottles units
FDA Drug
Class II
Ongoing
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tabl
August 6, 2024
Dr. Reddy's Laboratories, Inc.
103,298 bottles units
FDA Drug
Class II
Ongoing
HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d)
August 5, 2024
Zeco LLC
FDA Drug
Class II
Ongoing
Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings R
August 5, 2024
Zeco LLC
604 units
FDA Drug
Class II
Terminated
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX
August 2, 2024
EMPOWER CLINIC SERVICES LLC
2,797 units
FDA Drug
Class III
Completed
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
August 1, 2024
Amneal Pharmaceuticals LLC
12,624 bottles units
FDA Drug
Class I
Ongoing
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
August 1, 2024
Baxter Healthcare Corporation
44,208 containers units
FDA Drug
Class II
Terminated
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-
July 31, 2024
Granules Pharmaceuticals Inc
11,808 500-count Bottles units
FDA Drug
Class II
Ongoing
Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Lim
July 31, 2024
Glenmark Pharmaceuticals Inc., USA
2404 bottles units
FDA Drug
Class II
Ongoing
Progesterone Injection, USP, 500 mg 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.
July 26, 2024
Eugia US LLC
17136 vials units
FDA Drug
Class I
Ongoing
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
July 24, 2024
B. Braun Medical Inc
63,444 containers units
FDA Drug
Class II
Ongoing
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufact
July 23, 2024
FDC Limited
66,528 bottles units
FDA Drug
Class II
Ongoing
Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah
July 22, 2024
Glenmark Pharmaceuticals Inc., USA
14,004 cartons units
FDA Drug
Class I
Ongoing
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
July 18, 2024
MAIN PRODUCTS INC
57, 340 bottles units
FDA Drug
Class II
Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jerse
July 18, 2024
FDC Limited
362,544 bottles units
FDA Drug
Class III
Terminated
Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot
July 18, 2024
Granules Consumer Health Inc.
21,192 Bottles units