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.

2023-12-27FDA-DrugInsight Pharmaceuticals CorporationClass I
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591, UPC 363736532611.
Chemical Contamination; presence of benzene.
2023-12-20FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass II
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. 259/15, Dadra-396 191, (U.T. of D & NH), India. NDC 62756-589-88
Failed Impurities/Degradation Specifications
2023-12-20FDA-DrugSiegfried Barbera, SLClass III
Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66
Failed Dissolution Specifications
2023-12-20FDA-DrugLupin Pharmaceuticals Inc.Class II
Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01
Failed Dissolution Specifications
2023-12-13FDA-DrugSTAQ Pharma, Inc.Class II
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,
STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
2023-12-13FDA-DrugBaxter Healthcare CorporationClass II
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25
Failed pH Specifications
2023-12-13FDA-DrugNovartis Pharmaceuticals CorporationClass I
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
2023-12-13FDA-DrugKINDER FARMS LLCClass II
KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-096-02, UPC 850001805698.
Failed Impurities/Degradation Specifications
2023-12-13FDA-DrugKINDER FARMS LLCClass II
KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04, UPC 850001805728.
Failed Impurities/Degradation Specifications
2023-12-13FDA-DrugWells Pharma of Houston LLCClass II
ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10
Lack of assurance of sterility.
2023-12-13FDA-DrugRight Value Drug Stores, LLC dba Carie Boyd's Prescription ShopClass III
LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1
Product Mix-up: Incorrect Product Formulation
2023-12-13FDA-DrugPadagis US LLCClass II
Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
2023-12-13FDA-DrugSUGARMDS LLCClass I
Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34952.
MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
2023-12-13FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass III
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
Failed Dissolution Specifications
2023-12-06FDA-DrugBotanical BeClass I
Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
2023-12-06FDA-DrugBotanical BeClass I
Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
2023-12-06FDA-DrugBotanical BeClass I
Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
2023-12-06FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class I
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
2023-12-06FDA-DrugGolden State Medical Supply Inc.Class II
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
2023-12-06FDA-DrugGolden State Medical Supply Inc.Class II
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
2023-12-06FDA-DrugGolden State Medical Supply Inc.Class II
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
2023-12-06FDA-DrugTeva Pharmaceuticals USA, IncClass III
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
OOS for viscosity
2023-12-06FDA-DrugVistaPharm LLCClass III
Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08
Failed Excipient Specifications: high content of ethylene glycol (EG)
2023-12-06FDA-DrugFagron Compounding ServicesClass III
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, KS 67226. NDC 71266-8240-01
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
2023-12-06FDA-DrugGlenmark Pharmaceuticals Inc., USAClass II
Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
2023-12-06FDA-DrugGlenmark Pharmaceuticals Inc., USAClass II
Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-406-01
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
2023-12-06FDA-DrugApotex Corp.Class II
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
2023-12-06FDA-DrugApotex Corp.Class II
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
2023-12-06FDA-DrugApotex Corp.Class II
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
2023-12-06FDA-DrugApotex Corp.Class II
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

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