Drugs Recalls
17,415 recalls in this category
FDA Drug
Class II
Ongoing
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, D
March 4, 2024
Sun Pharmaceutical Industries Inc.
7,488 bottles units
FDA Drug
Class II
Completed
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03
March 1, 2024
Specialty Process Labs LLC
217 units units
FDA Drug
Class II
Completed
S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
March 1, 2024
Specialty Process Labs LLC
26 units units
FDA Drug
Class II
Ongoing
hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150
February 29, 2024
Optikem International, Inc.
46,621 bottles units
FDA Drug
Class II
Ongoing
TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.
February 29, 2024
Optikem International, Inc.
47,832 bottles units
FDA Drug
Class II
Ongoing
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility,
February 29, 2024
SSM Health Care St. Louis DBA SSM St. Clare Health Center
140 vials units
FDA Drug
Class II
Ongoing
TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.
February 29, 2024
Optikem International, Inc.
139,656 bottles units
FDA Drug
Class II
Ongoing
TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.
February 29, 2024
Optikem International, Inc.
7,248 bottles units
FDA Drug
Class II
Ongoing
TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.
February 29, 2024
Optikem International, Inc.
9,936 bottles units
FDA Drug
Class II
Ongoing
TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.
February 29, 2024
Optikem International, Inc.
106,704 bottles units
FDA Drug
Class II
Ongoing
TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.
February 29, 2024
Optikem International, Inc.
10,536 bottles units
FDA Drug
Class II
Ongoing
TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.
February 29, 2024
Optikem International, Inc.
19,344 bottles units
FDA Drug
Class II
Ongoing
TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.
February 29, 2024
Optikem International, Inc.
30,240 bottles units
FDA Drug
Class II
Ongoing
TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.
February 29, 2024
Optikem International, Inc.
24,216 bottles units
FDA Drug
Class II
Ongoing
Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing F
February 29, 2024
SSM Health Care St. Louis DBA SSM St. Clare Health Center
11,798 syringes units
FDA Drug
Class II
Terminated
Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520,
February 22, 2024
Eugia US LLC
1160 VIALS units
FDA Drug
Class II
Ongoing
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
February 20, 2024
Denver Solutions, LLC DBA Leiters Health
40,090 vials units
FDA Drug
Class II
Ongoing
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
February 20, 2024
Denver Solutions, LLC DBA Leiters Health
40,890 vials units
FDA Drug
Class III
Ongoing
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
February 20, 2024
Contract Pharmaceuticals Limited Canada
11,750 bottles units
FDA Drug
Class III
Ongoing
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
February 20, 2024
Contract Pharmaceuticals Limited Canada
45,875 bottles units
FDA Drug
Class II
Ongoing
Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11
February 20, 2024
Eugia US LLC
43,920 vials units
FDA Drug
Class II
Ongoing
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
February 20, 2024
Denver Solutions, LLC DBA Leiters Health
10,020 vials units
FDA Drug
Class II
Ongoing
Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
February 20, 2024
Eugia US LLC
335,940 vials units
FDA Drug
Class II
Ongoing
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01
February 20, 2024
Eugia US LLC
10,080 vials units
FDA Drug
Class II
Terminated
7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033
February 19, 2024
Seatex LLC
3 cases units
FDA Drug
Class II
Terminated
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX H
February 19, 2024
Seatex LLC
1,450 cases units
FDA Drug
Class II
Terminated
7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033
February 19, 2024
Seatex LLC
1,282 cases units
FDA Drug
Class II
Terminated
PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
February 19, 2024
Seatex LLC
274 cases units
FDA Drug
Class II
Terminated
PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471
February 19, 2024
Seatex LLC
480 cases units
FDA Drug
Class II
Ongoing
Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc,
February 16, 2024
Global Corporation
2345 boxes units
FDA Drug
Class II
Ongoing
Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 US
February 16, 2024
Global Corporation
9831 bottles units
FDA Drug
Class I
Ongoing
Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10
February 15, 2024
Eugia US LLC
1,552 10ml x 25/carton units
FDA Drug
Class II
Ongoing
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo
February 14, 2024
Golden State Medical Supply Inc.
59,712 bottles units
FDA Drug
Class II
Terminated
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
February 13, 2024
Amneal Pharmaceuticals of New York, LLC.
46,037 Bottles units
FDA Drug
Class II
Ongoing
Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01
February 12, 2024
Micro Labs Limited
24,768 bottles units
FDA Drug
Class II
Terminated
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Br
February 12, 2024
Mckesson Corporation
42 units units
FDA Drug
Class I
Terminated
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
February 12, 2024
FA Online Inc
400 capsules units
FDA Drug
Class II
Ongoing
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 3332
February 9, 2024
Apotex Corp.
292,752 bottles units
FDA Drug
Class II
Terminated
Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.
February 9, 2024
Micro Labs Limited
118,080 bottles units
FDA Drug
Class II
Terminated
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharm
February 9, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
8,198 units units
FDA Drug
Class III
Terminated
Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.qui
February 9, 2024
Stason Pharmaceuticals, Inc.
54, 131 bottles units
FDA Drug
Class II
Terminated
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
February 7, 2024
Mckesson Medical-Surgical Inc. Corporate Office
70 vials units
FDA Drug
Class II
Terminated
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
February 7, 2024
Mckesson Medical-Surgical Inc. Corporate Office
70 vials units
FDA Drug
Class II
Terminated
Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
February 7, 2024
Mckesson Medical-Surgical Inc. Corporate Office
70 vials units
FDA Drug
Class I
Ongoing
Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
February 6, 2024
Today The World
7000 boxes units
FDA Drug
Class I
Ongoing
SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
February 6, 2024
Today The World
11500 boxes units
FDA Drug
Class II
Ongoing
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1
February 6, 2024
Mallinckrodt Hospital Products Inc.
8 vials involved in recall (16,479 vials distributed) units
FDA Drug
Class I
Ongoing
Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
February 6, 2024
Today The World
5500 boxes units
FDA Drug
Class II
Ongoing
Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01
February 6, 2024
Mallinckrodt Hospital Products Inc.
421 vials involved in this recall (2,448 vials distributed) units
FDA Drug
Class II
Terminated
Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously f
February 5, 2024
Lupin Pharmaceuticals Inc.
N/A units