Drug Recalls
RSS ↗2,059 drug recalls from federal enforcement feeds.
Showing 1,801–1,850 of 2,059
- Class II
Drug Recall · February 29, 2024
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.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
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.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
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.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
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.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
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.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
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.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
SSM Health Care St. Louis DBA SSM St. Clare Health Center
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,Lack of Assurance of Sterility: Firm did not perform process validation.
- Class II
Drug Recall · February 29, 2024
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.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
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.Lack of Assurance of Sterility
- Class II
Drug Recall · February 22, 2024
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,Failed Stability Specification: Water determination was found not complying with specification.
- Class II
Drug Recall · February 20, 2024
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 55150-183-11Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- Class II
Drug Recall · February 20, 2024
Denver Solutions, LLC DBA Leiters Health
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Class II
Drug Recall · February 20, 2024
Denver Solutions, LLC DBA Leiters Health
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 71449-096-42Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Class II
Drug Recall · February 20, 2024
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 55150-183-10Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- Class III
Drug Recall · February 20, 2024
Contract Pharmaceuticals Limited Canada
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- Class II
Drug Recall · February 20, 2024
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 55150-314-01Failed Dissolution Specifications
- Class II
Drug Recall · February 20, 2024
Denver Solutions, LLC DBA Leiters Health
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 71449-090-42Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Class III
Drug Recall · February 20, 2024
Contract Pharmaceuticals Limited Canada
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- Class II
Drug Recall · February 19, 2024
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 HCGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Class II
Drug Recall · February 19, 2024
PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Class II
Drug Recall · February 19, 2024
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 77471CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Class II
Drug Recall · February 19, 2024
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 75033CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Class II
Drug Recall · February 19, 2024
7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Class II
Drug Recall · February 16, 2024
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 USStability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
- Class II
Drug Recall · February 16, 2024
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,Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
- Class I
Drug Recall · February 15, 2024
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 55150-223-10Presence of Particulate Matter
- Class II
Drug Recall · February 14, 2024
Golden State Medical Supply Inc.
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, CamarilloCGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
- Class II
Drug Recall · February 13, 2024
Amneal Pharmaceuticals of New York, LLC
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6Failed Impurities/Degradation Specifications: Out-of-specification test results.
- Class I
Drug Recall · February 12, 2024
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
- Class II
Drug Recall · February 12, 2024
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 BrCGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
- Class II
Drug Recall · February 12, 2024
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 42571-315-01CGMP Deviations: Out of specification for residual solvents.
- Class II
Drug Recall · February 9, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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 Pharman out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
- Class III
Drug Recall · February 9, 2024
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.quiFailed Dissolution Specifications: results slightly under spec at at 9-months.
- Class II
Drug Recall · February 9, 2024
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 3332CGMP Deviations: potential presence of Burkholderia cepacia complex
- Class II
Drug Recall · February 9, 2024
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.Failed Stability Specifications: Out of specification for blend uniformity.
- Class II
Drug Recall · February 7, 2024
Mckesson Medical-Surgical Inc. Corporate Office
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10cGMP Deviations: Products were stored outside the drug label specifications.
- Class II
Drug Recall · February 7, 2024
Mckesson Medical-Surgical Inc. Corporate Office
Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10cGMP Deviations: Products were stored outside the drug label specifications.
- Class II
Drug Recall · February 7, 2024
Mckesson Medical-Surgical Inc. Corporate Office
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01cGMP Deviations: Products were stored outside the drug label specifications.
- Class II
Drug Recall · February 6, 2024
Mallinckrodt Hospital Products Inc.
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 63004-8710-1cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
- Class II
Drug Recall · February 6, 2024
Mallinckrodt Hospital Products Inc.
Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
- Class I
Drug Recall · February 6, 2024
Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.comMarketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
- Class I
Drug Recall · February 6, 2024
SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
- Class I
Drug Recall · February 6, 2024
Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, NevadaMarketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
- Class II
Drug Recall · February 5, 2024
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 fLabeling: Incorrect or Missing Package Insert
- Class II
Drug Recall · February 5, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries,Failed Dissolution Specifications: Out of specification for dissolution.
- Class I
Drug Recall · February 5, 2024
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
- Class II
Drug Recall · February 2, 2024
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cSubpotent Drug: Out of specification for assay
- Class II
Drug Recall · February 1, 2024
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816.CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
- Class I
Drug Recall · February 1, 2024
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UChemical Contamination; presence of benzene.