Category
Drug and pharmaceutical recalls
17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2024-07-24FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
CGMP Deviations
- 2024-07-24FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01
CGMP Deviations
- 2024-07-24FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
Failed Dissolution Specifications
- 2024-07-24FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01
Failed Dissolution Specifications
- 2024-07-24FDA-DrugViatris IncClass IICardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
Failed Impurities/Degradation Specifications
- 2024-07-24FDA-DrugViatris IncClass IICardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
Failed Impurities/Degradation Specifications
- 2024-07-24FDA-DrugTeva Pharmaceuticals USA, IncClass IIFludrocortisone 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., North Wales, PA 19454, NDC 0555-0997-02.
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
- 2024-07-24FDA-DrugZydus Pharmaceuticals (USA) IncClass IICyanocobalamin 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.
Presence of particulate matter: glass
- 2024-07-24FDA-DrugBrands International CorporationClass IIOatmeal 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, L3X 2S2, Made in Canada.
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
- 2024-07-24FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IINitrofurantoin 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, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.
Failed Dissolution Specifications
- 2024-07-17FDA-DrugRising Pharma Holding, Inc.Class IIIDiflorasone 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
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
- 2024-07-17FDA-DrugZydus Pharmaceuticals (USA) IncClass IIIMicafungin 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 16714-301-01 (vial), NDC 16714-301-10 (outer box).
Cross contamination with other products
- 2024-07-17FDA-DrugZydus Pharmaceuticals (USA) IncClass IIIMicafungin 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, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).
Cross contamination with other products
- 2024-07-17FDA-DrugTAILSTORM HEALTH INCClass IILidocaine 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 81483-0038-0, UPC 3 81483 00380 2
Subpotent Drug: reduced efficacy for epinephrine
- 2024-07-17FDA-DrugZydus Pharmaceuticals (USA) IncClass IIIVerapamil 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 Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5.
Cross contamination with other products.
- 2024-07-17FDA-DrugZydus Pharmaceuticals (USA) IncClass IIIVerapamil 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 carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,
Cross contamination with other products.
- 2024-07-17FDA-DrugEquibal IncClass IIBlemfree 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
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
- 2024-07-17FDA-DrugAmerisource Health Services LLCClass IIbuPROPion 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: 60687-782-01.
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
- 2024-07-17FDA-DrugSYNCHRONICITY SPA INC, DBA SUNTEClass IIsuntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 - IVORY b) NDC: 69949-156-01, UPC: 854245006224 - NUDE c) NDC: 69949-152-01, UPC: 854245006187 - BUFF d) NDC: 69949-153-01, UPC: 854245006194 - SAND e) NDC: 69949-155-01, UPC: 854245006217 - BRONZE f) NDC: 69949-157-01, UPC: 854245006446 - MOCHA
CGMP Deviations
- 2024-07-17FDA-DrugSYNCHRONICITY SPA INC, DBA SUNTEClass Isuntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
- 2024-07-17FDA-DrugBaxter Healthcare CorporationClass IIDianeal 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 USA. NDC: 0941-0457-01
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
- 2024-07-10FDA-DrugIntegrity ProductsClass ITo the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
- 2024-07-10FDA-DrugIntegrity ProductsClass IRAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
- 2024-07-10FDA-DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesClass IIVenlafaxine 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 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
- 2024-07-10FDA-DrugDr. Reddy's Laboratories, Inc.Class IIAllopurinol 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.
Presence of foreign substance.
- 2024-07-10FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIDecitabine 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, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40.
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
- 2024-07-10FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIEszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30
Failed Impurities/Degradation Specifications: Related Substances
- 2024-07-10FDA-DrugAccord Healthcare, Inc.Class IIIDodex 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 Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308
Subpotent drug: out of specification results
- 2024-07-10FDA-DrugTrigen LaboratoriesClass IIMethylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
- 2024-07-10FDA-DrugLittle Moon Essentials LLCClass IILittle 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 Code 6 73673 88798 0, NDC 70722-319-04; Little Moon Essentials LLC Dania Beach, Fl 33004
CGMP deviations
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