Drugs Recalls
17,415 recalls in this category
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 III
Ongoing
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30
June 4, 2024
Dr. Reddy's Laboratories, Inc.
13,752 bottles units
FDA Drug
Class II
Terminated
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA
May 31, 2024
RemedyRepack Inc.
8 bottles units
FDA Drug
Class III
Terminated
Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic Products, Inc., Berkley Springs, WV 25411, UPC 7 40640 64300 6.
May 31, 2024
Washington Homeopathic Products, Inc.
11 kits units
FDA Drug
Class II
Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-D
May 30, 2024
Glenmark Pharmaceuticals Inc., USA
FDA Drug
Class I
Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-D
May 30, 2024
Glenmark Pharmaceuticals Inc., USA
285,840 bottles units
FDA Drug
Class I
Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-D
May 30, 2024
Glenmark Pharmaceuticals Inc., USA
36,630 bottles units
FDA Drug
Class II
Terminated
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited,
May 30, 2024
Lupin Pharmaceuticals Inc.
3,552 bottles units
FDA Drug
Class II
Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-D
May 30, 2024
Glenmark Pharmaceuticals Inc., USA
FDA Drug
Class III
Ongoing
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-
May 28, 2024
Organon Llc
FDA Drug
Class III
Ongoing
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-0
May 28, 2024
Organon Llc
2,886 units units
FDA Drug
Class I
Ongoing
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
May 28, 2024
Sagent Pharmaceuticals
762 vials units
FDA Drug
Class II
Terminated
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02
May 28, 2024
Denison Pharmaceuticals, LLC
113,544 bottles units
FDA Drug
Class III
Ongoing
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-0
May 28, 2024
Organon Llc
2,551 units units
FDA Drug
Class II
Terminated
Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-7505
May 28, 2024
Consumer Product Partners, LLC
1015 cases units
FDA Drug
Class II
Completed
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,
May 28, 2024
Winder Laboratories, LLC
473 cases (5676 Bottles) units
FDA Drug
Class I
Ongoing
Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
May 28, 2024
Sagent Pharmaceuticals
2806 vials units
FDA Drug
Class II
Ongoing
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 85
May 24, 2024
SYNCHRONICITY SPA INC, DBA SUNTE
8202 tubes units
FDA Drug
Class I
Ongoing
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
May 24, 2024
SYNCHRONICITY SPA INC, DBA SUNTE
1,902 tubes units
FDA Drug
Class II
Ongoing
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52
May 23, 2024
Dr. Reddy's Laboratories, Inc.
13,880 vials units
FDA Drug
Class II
Ongoing
Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made
May 23, 2024
Eugia US LLC
70,125 vials units
FDA Drug
Class III
Ongoing
Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10
May 22, 2024
Eugia US LLC
15,500 single dose vials units
FDA Drug
Class II
Ongoing
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370
May 22, 2024
MexHealth LLC
20 bottles units
FDA Drug
Class II
Ongoing
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., L
May 20, 2024
Pfizer Inc.
84,710 cartridges units
FDA Drug
Class II
Ongoing
Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730
May 20, 2024
Contract Pharmacal Corporation
14,616 bottles units
FDA Drug
Class II
Terminated
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
May 20, 2024
Genentech Inc
Lot:3618858 = 105,759; Lot:3618873 =90,359 units
FDA Drug
Class II
Ongoing
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc.,
May 20, 2024
Pfizer Inc.
220,400 cartridges units
FDA Drug
Class II
Completed
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berk
May 17, 2024
Breckenridge Pharmaceutical, Inc
165,678, 90-count bottles units
FDA Drug
Class III
Terminated
Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: Vi
May 17, 2024
GlaxoSmithKline, LLC.
463 Cartons units
FDA Drug
Class III
Ongoing
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0
May 16, 2024
Zydus Pharmaceuticals USA Inc
21,360 units units
FDA Drug
Class III
Ongoing
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 6498
May 16, 2024
Rising Pharma Holding, Inc.
N/A units
FDA Drug
Class III
Ongoing
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08
May 16, 2024
Zydus Pharmaceuticals USA Inc
13,440 units units
FDA Drug
Class II
Terminated
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Ol
May 15, 2024
Regeneron Pharmaceuticals Inc
405,725 Prefilled syringes units
FDA Drug
Class II
Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640
May 14, 2024
Imprimis NJOF, LLC
14,180 vials units
FDA Drug
Class II
Ongoing
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 4
May 14, 2024
Imprimis NJOF, LLC
136,005 units units
FDA Drug
Class II
Ongoing
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71
May 14, 2024
Imprimis NJOF, LLC
39,700 vials units
FDA Drug
Class II
Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-
May 14, 2024
Imprimis NJOF, LLC
74,440 units units
FDA Drug
Class II
Terminated
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc.
May 14, 2024
American Regent, Inc.
4,136 cartons (10 vials in each carton) units
FDA Drug
Class II
Ongoing
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 7138
May 14, 2024
Imprimis NJOF, LLC
4,280 boxes units
FDA Drug
Class II
Ongoing
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Le
May 14, 2024
Imprimis NJOF, LLC
38,060 vials units
FDA Drug
Class II
Ongoing
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
May 14, 2024
Imprimis NJOF, LLC
165,920 vials units
FDA Drug
Class II
Ongoing
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
May 14, 2024
Imprimis NJOF, LLC
18,980 vials units
FDA Drug
Class II
Terminated
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Bar
May 13, 2024
Golden State Medical Supply Inc.
21,655 (30 count bottle), 34,149 (90 count bottle) units
FDA Drug
Class II
Ongoing
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06
May 13, 2024
Glenmark Pharmaceuticals Inc., USA
13296 cartons units
FDA Drug
Class II
Ongoing
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06
May 13, 2024
Glenmark Pharmaceuticals Inc., USA
2400 cartons units
FDA Drug
Class II
Terminated
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
May 13, 2024
American Regent, Inc.
2,352 vials units
FDA Drug
Class III
Ongoing
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.
May 10, 2024
Bryant Ranch Prepack Inc.
156 bottles units
FDA Drug
Class II
Ongoing
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99
May 10, 2024
Glenmark Pharmaceuticals Inc., USA
11,976 cartons units
FDA Drug
Class III
Ongoing
Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by
May 10, 2024
Bryant Ranch Prepack Inc.
61 Bottles units
FDA Drug
Class III
Ongoing
Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled b
May 10, 2024
Bryant Ranch Prepack Inc.
104 bottles units