Drugs Recalls
17,415 recalls in this category
FDA Drug
Class II
Ongoing
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Guja
May 7, 2025
Alembic Pharmaceuticals Limited
N/A units
FDA Drug
Class I
Ongoing
ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N
May 6, 2025
EnShiShiXiangNiShangMaoYouXianGongSi
600, 20-count cartons units
FDA Drug
Class II
Ongoing
Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-85
May 2, 2025
Empower Clinic Services LLC dba Empower Pharmacy
8,230 vials units
FDA Drug
Class II
Ongoing
TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #21
April 28, 2025
BSO LLC
1,974 vials units
FDA Drug
Class II
Ongoing
temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.
April 28, 2025
Siddha Flower Essences, LLC.
N/A units
FDA Drug
Class II
Ongoing
TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #21
April 28, 2025
BSO LLC
2,762 vials units
FDA Drug
Class II
Ongoing
TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 802
April 28, 2025
BSO LLC
1,964 vials units
FDA Drug
Class II
Ongoing
TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #21
April 28, 2025
BSO LLC
1,447 vials units
FDA Drug
Class II
Ongoing
TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Dri
April 28, 2025
BSO LLC
355 vials units
FDA Drug
Class II
Ongoing
Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthc
April 25, 2025
Mckesson Medical-Surgical Inc. Corporate Office
15 units
FDA Drug
Class II
Ongoing
Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01
April 25, 2025
Mckesson Medical-Surgical Inc. Corporate Office
3 units
FDA Drug
Class II
Terminated
CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
10,128 Bottles units
FDA Drug
Class II
Terminated
Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
383,904 Tubes units
FDA Drug
Class II
Terminated
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
616,160 Tubes units
FDA Drug
Class II
Terminated
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
150,768 Tubes units
FDA Drug
Class II
Terminated
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
160,848 Tubes units
FDA Drug
Class II
Terminated
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
216,720 Tubes units
FDA Drug
Class II
Terminated
Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
391,680 Tubes units
FDA Drug
Class II
Terminated
Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01,
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
6,372 Tubes units
FDA Drug
Class II
Terminated
Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, ND
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
9,984 Tubes units
FDA Drug
Class II
Terminated
Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10096 77158 2.
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
10,000 Tubes units
FDA Drug
Class II
Terminated
Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
9,000 Bottles units
FDA Drug
Class II
Terminated
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
19,500 Tubes units
FDA Drug
Class II
Terminated
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
615, 600 Tubes units
FDA Drug
Class II
Terminated
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
1,559,000 Sachets units
FDA Drug
Class II
Terminated
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
498,960 Tubes units
FDA Drug
Class II
Terminated
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
4,176 boxes units
FDA Drug
Class II
Terminated
CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
10,788 Tubes units
FDA Drug
Class II
Terminated
KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
16,248 Jars units
FDA Drug
Class II
Terminated
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
9,336 Tubes units
FDA Drug
Class II
Terminated
KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-10
April 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED
11,808 Jars units
FDA Drug
Class II
Ongoing
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulask
April 23, 2025
BRS Analytical Services, LLC
13,872 cases (24 cartons per case) units
FDA Drug
Class II
Ongoing
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski,
April 23, 2025
BRS Analytical Services, LLC
1,610 cases (24 cartons per case) units
FDA Drug
Class II
Ongoing
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
April 23, 2025
BRS Analytical Services, LLC
14,333 cases (24 cartons per case) units
FDA Drug
Class II
Ongoing
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distribu
April 23, 2025
BRS Analytical Services, LLC
13,104 cases (24 cartons per case) units
FDA Drug
Class II
Ongoing
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed
April 23, 2025
BRS Analytical Services, LLC
32,876 cases (24 cartons per case) units
FDA Drug
Class II
Ongoing
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
April 22, 2025
RemedyRepack Inc.
23 bottles/30 count- 690 capsules units
FDA Drug
Class II
Ongoing
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520
April 21, 2025
Eugia US LLC
N/A units
FDA Drug
Class II
Ongoing
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
April 21, 2025
Mckesson Medical-Surgical Inc. Corporate Office
2 Pre-filled syringes units
FDA Drug
Class II
Ongoing
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, N
April 21, 2025
Eugia US LLC
18,867 bags units
FDA Drug
Class II
Ongoing
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
April 21, 2025
Mckesson Medical-Surgical Inc. Corporate Office
3 Vials units
FDA Drug
Class II
Ongoing
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
April 21, 2025
Mckesson Medical-Surgical Inc. Corporate Office
6 Pre-filled syringes units
FDA Drug
Class II
Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jers
April 18, 2025
FDC Limited
60428 bottles units
FDA Drug
Class II
Ongoing
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carto
April 18, 2025
American Regent, Inc.
29,777 (cartons of 10 x 10mL vials) units
FDA Drug
Class II
Ongoing
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
April 18, 2025
American Regent, Inc.
7,249 (cartons of 10 x 10 mL vials) units
FDA Drug
Class II
Ongoing
Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
April 18, 2025
Preferred Pharmaceuticals, Inc
1190 Bottles units
FDA Drug
Class I
Ongoing
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewate
April 17, 2025
Amneal Pharmaceuticals LLC
62 (12x100mL) bags units
FDA Drug
Class II
Terminated
Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99
April 15, 2025
Pharmadel, LLC
6,048 bottles units
FDA Drug
Class II
Terminated
Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30
April 15, 2025
Pharmadel, LLC
10,752 bottles units
FDA Drug
Class II
Terminated
DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15
April 15, 2025
Pharmadel, LLC
9504 bottles units