Drugs Recalls
17,415 recalls in this category
FDA Drug
Class II
Ongoing
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa
August 7, 2025
Glenmark Pharmaceuticals Inc., USA
44,328 bottles units
FDA Drug
Class II
Ongoing
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahw
August 7, 2025
Glenmark Pharmaceuticals Inc., USA
4,800 bottles units
FDA Drug
Class II
Ongoing
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, In
August 6, 2025
Glenmark Pharmaceuticals Inc., USA
14,976 bottles units
FDA Drug
Class II
Ongoing
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775,
August 6, 2025
Glenmark Pharmaceuticals Inc., USA
17, 496 bottles units
FDA Drug
Class II
Ongoing
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westm
August 6, 2025
Westminster Pharmaceuticals LLC
4,456 1000-count bottles units
FDA Drug
Class II
Ongoing
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westmi
August 6, 2025
Westminster Pharmaceuticals LLC
16,672 1000-count bottles units
FDA Drug
Class III
Ongoing
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK C
August 5, 2025
Haleon US Holdings LLC
46,692 tubes units
FDA Drug
Class II
Ongoing
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer packa
August 5, 2025
Cardinal Health Inc.
10 bags units
FDA Drug
Class II
Ongoing
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 0
August 5, 2025
Sun Pharmaceutical Industries Inc.
11,328 bottles units
FDA Drug
Class II
Ongoing
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
August 4, 2025
B. Braun Medical Inc
23,100 containers units
FDA Drug
Class II
Ongoing
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.
August 4, 2025
B. Braun Medical Inc
74,088 containers units
FDA Drug
Class II
Ongoing
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
August 4, 2025
Pfizer Inc.
49,620 vials units
FDA Drug
Class II
Ongoing
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
August 4, 2025
Pfizer Inc.
15,750 vials units
FDA Drug
Class II
Ongoing
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
July 30, 2025
Cardinal Health Inc.
3 units units
FDA Drug
Class II
Ongoing
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 286
July 30, 2025
Exela Pharma Sciences LLC
N/A units
FDA Drug
Class II
Ongoing
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
July 30, 2025
Cardinal Health Inc.
4 units units
FDA Drug
Class II
Ongoing
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
July 30, 2025
Cardinal Health Inc.
6 units units
FDA Drug
Class II
Ongoing
Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC 60793-851-01.
July 29, 2025
Pfizer
29, 004 bottles units
FDA Drug
Class II
Ongoing
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
July 29, 2025
Amerisource Health Services LLC
26,992 blister packs units
FDA Drug
Class II
Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pha
July 25, 2025
Breckenridge Pharmaceutical, Inc
1,856 bottles units
FDA Drug
Class II
Ongoing
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., B
July 25, 2025
Alembic Pharmaceuticals Limited
9,492 bottles units
FDA Drug
Class III
Ongoing
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence
July 24, 2025
Cipla USA, Inc.
20352 packs (1x 200 MD) units
FDA Drug
Class II
Ongoing
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
July 22, 2025
Hikma Pharmaceuticals USA Inc.
382,775 1mL vials units
FDA Drug
Class II
Ongoing
BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu,
July 22, 2025
Taizhou Kangping Medical Science And Technology Co., Ltd.
3.85 million Cartons units
FDA Drug
Class II
Ongoing
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC
July 21, 2025
Ascend Laboratories LLC
8,568 bottles units
FDA Drug
Class II
Ongoing
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpa
July 21, 2025
Merck & Co Inc
51,320 cartons units
FDA Drug
Class II
Ongoing
Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.
July 21, 2025
YANGZHOU YULOU PAPER PRODUCTS CO., LTD
500 cases units
FDA Drug
Class II
Ongoing
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirklan
July 18, 2025
AEQUITA PHARMACY
190 vials units
FDA Drug
Class II
Ongoing
Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita
July 18, 2025
AEQUITA PHARMACY
176 vials units
FDA Drug
Class II
Ongoing
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkl
July 18, 2025
AEQUITA PHARMACY
194 vials units
FDA Drug
Class II
Ongoing
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland,
July 18, 2025
AEQUITA PHARMACY
170 vials units
FDA Drug
Class II
Ongoing
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland,
July 18, 2025
AEQUITA PHARMACY
290 vials units
FDA Drug
Class II
Ongoing
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, W
July 18, 2025
AEQUITA PHARMACY
236 vials units
FDA Drug
Class II
Ongoing
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirklan
July 18, 2025
AEQUITA PHARMACY
146 vials units
FDA Drug
Class II
Ongoing
Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirk
July 18, 2025
AEQUITA PHARMACY
221 vials units
FDA Drug
Class II
Ongoing
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirk
July 18, 2025
AEQUITA PHARMACY
155 vials units
FDA Drug
Class II
Ongoing
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland,
July 18, 2025
AEQUITA PHARMACY
160 vials units
FDA Drug
Class II
Ongoing
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkl
July 18, 2025
AEQUITA PHARMACY
158 vials units
FDA Drug
Class II
Ongoing
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland,
July 18, 2025
AEQUITA PHARMACY
139 vials units
FDA Drug
Class II
Ongoing
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland,
July 18, 2025
AEQUITA PHARMACY
143 vials units
FDA Drug
Class I
Ongoing
PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
July 17, 2025
DermaRite Industries, LLC
5,703 bottles units
FDA Drug
Class I
Ongoing
DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
July 17, 2025
DermaRite Industries, LLC
249 bottles units
FDA Drug
Class I
Ongoing
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092
July 17, 2025
DermaRite Industries, LLC
11,321 bag in boxes units
FDA Drug
Class I
Ongoing
KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
July 17, 2025
DermaRite Industries, LLC
6,973 cartridges units
FDA Drug
Class II
Ongoing
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, I
July 15, 2025
Breckenridge Pharmaceutical, Inc
1,829 60-count bottles units
FDA Drug
Class II
Ongoing
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO
July 11, 2025
Nostrum Laboratories, Inc.
60,608 bottles units
FDA Drug
Class II
Ongoing
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313
July 10, 2025
A.P. Deauville, LLC
21,265 cases units
FDA Drug
Class II
Ongoing
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10,
July 10, 2025
Pfizer Inc.
50,855 2 mL vials units
FDA Drug
Class II
Ongoing
Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 81519501
July 10, 2025
A.P. Deauville, LLC
22,482 Cases units
FDA Drug
Class II
Ongoing
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , S
July 10, 2025
Pfizer Inc.
19,279 vials units