Drugs Recalls
17,415 recalls in this category
FDA Drug
Class II
Terminated
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
January 10, 2024
BE PHARMACEUTICALS AG
22,176 Vials units
FDA Drug
Class II
Ongoing
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
January 10, 2024
MEDLINE INDUSTRIES, LP - Northfield
1,786 tubes units
FDA Drug
Class II
Ongoing
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
January 8, 2024
Teva Pharmaceuticals USA, Inc.
10,672 30-count bottles units
FDA Drug
Class II
Terminated
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
January 5, 2024
Lupin Pharmaceuticals Inc.
165,60 bottles units
FDA Drug
Class II
Terminated
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
January 5, 2024
Lupin Pharmaceuticals Inc.
15,576 Bottles units
FDA Drug
Class II
Terminated
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:
January 4, 2024
Glenmark Pharmaceuticals Inc., USA
38,496 bottles units
FDA Drug
Class I
Terminated
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
January 4, 2024
Azurity Pharmaceuticals, Inc.
4,662 bottles units
FDA Drug
Class II
Terminated
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
January 3, 2024
Lupin Pharmaceuticals Inc.
4,608 Bottles units
FDA Drug
Class II
Completed
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15
January 2, 2024
Dr. Reddy's Laboratories, Inc.
38,952 bottles units
FDA Drug
Class II
Ongoing
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
December 29, 2023
Rising Pharma Holding, Inc.
47,976 bottles units
FDA Drug
Class II
Terminated
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
December 29, 2023
Strides Pharma INC
396 50-count bottles units
FDA Drug
Class II
Ongoing
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
December 29, 2023
Ascend Laboratories LLC
3,288 bottles units
FDA Drug
Class II
Ongoing
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.
December 28, 2023
Fresenius Medical Care Holdings, Inc.
69,590 bags units
FDA Drug
Class II
Ongoing
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
December 28, 2023
Seaway Pharma Inc.
4,176 bottles units
FDA Drug
Class II
Ongoing
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
December 28, 2023
Seaway Pharma Inc.
8,160 bottles units
FDA Drug
Class I
Ongoing
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.
December 28, 2023
Denver Solutions, LLC DBA Leiters Health
10,152 IV bags units
FDA Drug
Class I
Ongoing
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
December 28, 2023
Denver Solutions, LLC DBA Leiters Health
8,976 IV bags units
FDA Drug
Class I
Ongoing
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.
December 28, 2023
Denver Solutions, LLC DBA Leiters Health
7,548 IV bags units
FDA Drug
Class I
Ongoing
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.
December 28, 2023
Denver Solutions, LLC DBA Leiters Health
13,920 IV bags units
FDA Drug
Class I
Ongoing
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.
December 28, 2023
Denver Solutions, LLC DBA Leiters Health
29,016 IV bags units
FDA Drug
Class II
Ongoing
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
December 28, 2023
Seaway Pharma Inc.
7,992 bottles units
FDA Drug
Class I
Ongoing
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.
December 28, 2023
Denver Solutions, LLC DBA Leiters Health
12,564 IV bags units
FDA Drug
Class II
Ongoing
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
December 28, 2023
Seaway Pharma Inc.
7,992 bottles units
FDA Drug
Class II
Terminated
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewate
December 26, 2023
Amneal Pharmaceuticals of New York, LLC.
21,452/100 count bottles units
FDA Drug
Class III
Ongoing
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose
December 26, 2023
Amerisource Health Services LLC
6,344 cartons units
FDA Drug
Class I
Ongoing
Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 0705
December 26, 2023
Haleon US Holdings LLC
a) 31,632 bottles; b) 336,528 bottles units
FDA Drug
Class I
Ongoing
Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
December 26, 2023
Haleon US Holdings LLC
21,900 bottles units
FDA Drug
Class II
Ongoing
Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distributed by: Walgreen Co, 200 Wilmot Rd, Deerfield, IL 60015, NDC 0363-0427-98.
December 21, 2023
Pharma Nobis LLC
49,716 Bottles units
FDA Drug
Class I
Ongoing
Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carto
December 21, 2023
Pfizer Inc.
24400 Cartons units
FDA Drug
Class I
Completed
Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made
December 21, 2023
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
34,704 cans units
FDA Drug
Class I
Ongoing
8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-
December 21, 2023
Pfizer Inc.
21200 Cartons units
FDA Drug
Class II
Ongoing
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-312-10.
December 21, 2023
Pharma Nobis LLC
7,404 Bottles units
FDA Drug
Class II
Ongoing
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
December 21, 2023
Pharma Nobis LLC
13,344 bottles units
FDA Drug
Class II
Ongoing
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-311-10.
December 21, 2023
Pharma Nobis LLC
53,268 Bottles units
FDA Drug
Class II
Ongoing
Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral Solution, Cherry Flavor 10 fl. oz, Distributed by AmerisourceBergen, 1 West First Ave, Conshochoken, PA 19428, NDC
December 21, 2023
Pharma Nobis LLC
24,684 Bottles units
FDA Drug
Class I
Ongoing
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 04
December 21, 2023
Pfizer Inc.
34000 Cartons units
FDA Drug
Class I
Ongoing
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18
December 21, 2023
Pfizer
3,546 vials units
FDA Drug
Class II
Terminated
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.
December 20, 2023
Lupin Pharmaceuticals Inc.
100=29,184 bottles; 500=2922 bottles units
FDA Drug
Class II
Terminated
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
December 15, 2023
Dr. Reddy's Laboratories, Inc.
8,280 bottles units
FDA Drug
Class II
Ongoing
Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.
December 13, 2023
Private Label Partners, Inc.
3,396 bottles units
FDA Drug
Class III
Terminated
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869
December 12, 2023
GlaxoSmithKline, LLC.
67,508 inhalers units
FDA Drug
Class II
Ongoing
NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00
December 11, 2023
Fagron, Inc
13 containers units
FDA Drug
Class II
Ongoing
NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 5155
December 11, 2023
Fagron, Inc
46 containers units
FDA Drug
Class II
Ongoing
NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552
December 11, 2023
Fagron, Inc
9 containers units
FDA Drug
Class II
Ongoing
NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 5155
December 11, 2023
Fagron, Inc
52 containers units
FDA Drug
Class II
Ongoing
Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packagin
December 11, 2023
Legacy Pharmaceutical Packaging LLC
161,664 bottles units
FDA Drug
Class III
Terminated
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
December 8, 2023
Azurity Pharmaceuticals, Inc.
2,220 bottles units
FDA Drug
Class II
Terminated
Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No.
December 4, 2023
Sun Pharmaceutical Industries Inc.
96,192 bottles units
FDA Drug
Class II
Completed
ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,
November 29, 2023
STAQ Pharma, Inc.
2616 bags units
FDA Drug
Class I
Ongoing
Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ
November 29, 2023
Meta Herbal
500 blister packs units