Drugs Recalls

FDA Drug Class I Ongoing

Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.

July 12, 2024 Supercore Products Group Inc. 729 units

FDA Drug Class I Ongoing

Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199

July 12, 2024 Supercore Products Group Inc. 615 units

FDA Drug Class I Ongoing

Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.

July 12, 2024 SoloVital 1,331 bottles units

FDA Drug Class I Ongoing

Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made

July 11, 2024 Aurobindo Pharma USA Inc 240 bottles units

FDA Drug Class I Terminated

Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977,

July 10, 2024 Endo Pharmaceuticals, Inc. 8,139 cartons units

FDA Drug Class II Terminated

Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradu

July 9, 2024 Sun Pharmaceutical Industries Inc. 5752 bottles units

FDA Drug Class I Ongoing

Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceut

July 8, 2024 Hikma Pharmaceuticals USA Inc. 31,400 bags units

FDA Drug Class II Ongoing

Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81

July 3, 2024 Tailstorm Health INC 12,525 10 mL vials units

FDA Drug Class III Ongoing

Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-0

July 2, 2024 Zydus Pharmaceuticals USA Inc n/a units

FDA Drug Class II Ongoing

Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manu

July 2, 2024 Sun Pharmaceutical Industries Inc. 2088 vials units

FDA Drug Class III Ongoing

Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per cart

July 2, 2024 Zydus Pharmaceuticals USA Inc 170,755 vials units

FDA Drug Class III Ongoing

Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceut

July 2, 2024 Zydus Pharmaceuticals USA Inc 8020 vials units

FDA Drug Class III Ongoing

Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534

July 2, 2024 Zydus Pharmaceuticals USA Inc 12720 vials units

FDA Drug Class III Terminated

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed

July 2, 2024 Novel Laboratories, Inc. d.b.a Lupin Somerset 13,200 cartons units

FDA Drug Class II Ongoing

Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Mad

June 28, 2024 Glenmark Pharmaceuticals Inc., USA a) 145,800 bottles; b) 1,368 bottles units

FDA Drug Class II Ongoing

Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc.

June 28, 2024 Teva Pharmaceuticals USA, Inc. 116,144 bottles units

FDA Drug Class II Terminated

Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.

June 27, 2024 Zydus Pharmaceuticals USA Inc 432250 vials units

FDA Drug Class III Ongoing

Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90

June 26, 2024 Dr. Reddy's Laboratories, Inc. 5,136 cartons units

FDA Drug Class II Ongoing

Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216

June 26, 2024 Guru Inc.

FDA Drug Class II Completed

Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 01450 90008 6, NDC # 53228-002-01, Equibal Labs, Inc

June 26, 2024 Equibal Inc 90/1 oz. tubes and 248/4 oz. bottles units

FDA Drug Class II Completed

Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

June 26, 2024 Medisca Inc. 113 bottles units

FDA Drug Class II Terminated

Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-120

June 26, 2024 RemedyRepack Inc. 142 blister cards, 30 per blister card units

FDA Drug Class III Ongoing

Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, NDC 73423-003-01; UPC Code: 8-40078-56493-2

June 25, 2024 GLOBAL WIDGET LLC 18540 bottles units

FDA Drug Class III Ongoing

Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC Code: 8-40078-56612-7

June 25, 2024 GLOBAL WIDGET LLC 2082 bottles units

FDA Drug Class III Ongoing

Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, UPC code: 8-40078-56731-5

June 25, 2024 GLOBAL WIDGET LLC 2466 bottles units

FDA Drug Class III Ongoing

Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC code: 8-40078-56497-0

June 25, 2024 GLOBAL WIDGET LLC 11130 bottles units

FDA Drug Class I Ongoing

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceutical

June 25, 2024 Amerisource Health Services LLC 61,231 bottles units

FDA Drug Class III Ongoing

SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals I

June 24, 2024 Neilmed Pharmaceuticals Inc 20,370 bottles units

FDA Drug Class II Ongoing

buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782

June 24, 2024 Amerisource Health Services LLC 2,484 cartons units

FDA Drug Class III Ongoing

Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60

June 24, 2024 Rising Pharma Holding, Inc. 868 tubes units

FDA Drug Class I Terminated

Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2

June 21, 2024 A-S Medication Solutions LLC. 429 bottles units

FDA Drug Class II Terminated

Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Lt

June 21, 2024 Zydus Pharmaceuticals USA Inc a) 13,128 bottles; b) 252 bottles units

FDA Drug Class II Ongoing

Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722

June 20, 2024 Little Moon Essentials LLC 6,312 tin and glass jars units

FDA Drug Class II Ongoing

Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 7367

June 20, 2024 Little Moon Essentials LLC 1654 glass jars units

FDA Drug Class II Ongoing

Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC

June 20, 2024 Little Moon Essentials LLC 1264 glass jars units

FDA Drug Class II Ongoing

Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 882

June 20, 2024 Little Moon Essentials LLC 320 metal tins units

FDA Drug Class II Ongoing

Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC

June 20, 2024 Little Moon Essentials LLC 20 spray bottles units

FDA Drug Class II Ongoing

Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, ND

June 20, 2024 Little Moon Essentials LLC 788 glass jars units

FDA Drug Class II Ongoing

Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b) 3 OZ (85.05G) metal tin, UPC Code 6 73673 88208 4, NDC 70722-208-03; Little M

June 20, 2024 Little Moon Essentials LLC 165 metal tins units

FDA Drug Class II Ongoing

Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220

June 20, 2024 Little Moon Essentials LLC 1041 units

FDA Drug Class II Ongoing

DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogeni

June 18, 2024 Fresenius Medical Care Holdings, Inc. 183 cases units

FDA Drug Class II Terminated

Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 1

June 18, 2024 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 864 cartons units

FDA Drug Class III Terminated

Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limit

June 18, 2024 Accord Healthcare, Inc. 52,998 units

FDA Drug Class II Ongoing

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 U

June 17, 2024 Baxter Healthcare Corporation 6,874 bags units

FDA Drug Class II Terminated

Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10

June 17, 2024 Trigen Laboratories 10,448 100-count bottles units

FDA Drug Class II Ongoing

Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65

June 12, 2024 Pacira Pharmaceuticals, Inc. 40,517 kits units

FDA Drug Class II Ongoing

Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON,

June 10, 2024 Brands International Corporation 120,319 bottles units

FDA Drug Class II Terminated

Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01.

June 7, 2024 Dr. Reddy's Laboratories, Inc. 20,520 units units

FDA Drug Class I Terminated

STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01

June 5, 2024 Homeocare Laboratories, Inc. 31,811 x 1 fl. oz. spray bottle units

FDA Drug Class II Terminated

STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16

June 5, 2024 Homeocare Laboratories, Inc. 31,110 x 16 fl. oz. bottle units