Drug Recalls

1,842 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 1,751–1,800 of 1,842

Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 B
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-081
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 700040
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rai
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 700040300
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22,
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 700040
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceutical
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 700040
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceutic
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceutica
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 7
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow R
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 7000
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810
Lack of Assurance of Sterility
Class II
Drug Recall · November 9, 2023
SCA Pharmaceuticals, LLC
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
Lack of Assurance of Sterility
Class II
Drug Recall · February 16, 2022
TCP HRB ACQUISITON LLC
Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 00827755070085, NDC 41595-7103-1) and b) 6 oz. (170g) aerosol cans (UPC 00827755070
Chemical contamination: Presence of benzene
Class I
Drug Recall · February 16, 2022
TCP HRB ACQUISITON LLC
Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5518-06
Chemical contamination: Presence of benzene
Class I
Drug Recall · February 16, 2022
TCP HRB ACQUISITON LLC
Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5517-06
Chemical contamination: Presence of benzene
Class I
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 078
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridg
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 0
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC:
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 6923
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
Drug Recall · January 26, 2022
CARDINAL HEALTHCARE
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II