Drug Recalls

1,842 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 1,651–1,700 of 1,842

Drug Recall · January 19, 2024
Bestco LLC
Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II
Drug Recall · January 19, 2024
OMEZA LLC
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
CGMP Deviations
Class II
Drug Recall · January 19, 2024
Bestco LLC
Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., S
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pha
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/1
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Lim
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in Indi
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical I
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Su
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical In
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
Dr. Reddy's Laboratories, Inc.
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
Misprint on tablet
Class III
Drug Recall · January 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limi
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · January 18, 2024
Dr. Reddy's Laboratories, Inc.
Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01
Misprint on tablet
Class III
Drug Recall · January 17, 2024
Henry Schein Inc. and Glove Club HSI Gloves Inc.
Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Class II
Drug Recall · January 16, 2024
Den-Mat Holdings, LLC
Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC
CGMP Deviations: products may not conform to the labeled specifications.
Class II
Drug Recall · January 16, 2024
Den-Mat Holdings, LLC
OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000
CGMP Deviations: products may not conform to the labeled specifications.
Class II
Drug Recall · January 16, 2024
Ascend Laboratories, LLC
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laborato
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Class II
Drug Recall · January 15, 2024
Amneal Pharmaceuticals of New York, LLC
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class II
Drug Recall · January 12, 2024
Neptune Resources, LLC
Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I
Drug Recall · January 12, 2024
Neptune Resources, LLC
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I
Drug Recall · January 12, 2024
IntegraDose Compounding Services LLC
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
Subpotent Drug
Class II
Drug Recall · January 12, 2024
Neptune Resources, LLC
Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I
Drug Recall · January 12, 2024
Golden State Medical Supply Inc.
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
Failed Dissolution Specifications
Class II
Drug Recall · January 11, 2024
Par Sterile Products LLC
Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Pa
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class II
Drug Recall · January 11, 2024
Amerisource Health Services LLC
Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-
Failed Impurities/Degradation Specification.
Class II
Drug Recall · January 10, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 5332
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Class II
Drug Recall · January 10, 2024
BE PHARMACEUTICALS AG
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 20
Lack of Sterility Assurance: Aseptic process simulation failure.
Class II
Drug Recall · January 8, 2024
Teva Pharmaceuticals USA, Inc
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Failed Dissolution Specifications
Class II
Drug Recall · January 5, 2024
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, ND
Subpotent Drug and Failed Impurities/Degradation Specifications
Class II
Drug Recall · January 5, 2024
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC
Subpotent Drug and Failed Impurities/Degradation Specifications
Class II
Drug Recall · January 4, 2024
Azurity Pharmaceuticals, Inc.
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
Labeling: Label Mix-up
Class I
Drug Recall · January 4, 2024
Glenmark Pharmaceuticals Inc., USA
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District:
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class II
Drug Recall · January 3, 2024
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 681
Failed Impurities/Degradation Specifications
Class II
Drug Recall · January 2, 2024
Dr. Reddy's Laboratories, Inc.
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Class II
Drug Recall · December 29, 2023
Ascend Laboratories, LLC
Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 678
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class II
Drug Recall · December 29, 2023
Strides Pharma Inc.
Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380
Failed Dissolution Specifications
Class II
Drug Recall · December 29, 2023
Rising Pharma Holding, Inc.
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceut
Presence of Foreign Tablets/Capsules
Class II
Drug Recall · December 28, 2023
Seaway Pharma Inc.
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 6386
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II
Drug Recall · December 28, 2023
Seaway Pharma Inc.
Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancas
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II
Drug Recall · December 28, 2023
Denver Solutions, LLC DBA Leiters Health
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I
Drug Recall · December 28, 2023
Seaway Pharma Inc.
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, M
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II
Drug Recall · December 28, 2023
Denver Solutions, LLC DBA Leiters Health
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I
Drug Recall · December 28, 2023
Denver Solutions, LLC DBA Leiters Health
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I
Drug Recall · December 28, 2023
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Lack of Sterility Assurance
Class II
Drug Recall · December 28, 2023
Seaway Pharma Inc.
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II
Drug Recall · December 28, 2023
Denver Solutions, LLC DBA Leiters Health
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I
Drug Recall · December 28, 2023
Denver Solutions, LLC DBA Leiters Health
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I