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.
- 2024-03-13FDA-DrugStason Pharmaceuticals, Inc.Class IIIMercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
Failed Dissolution Specifications: results slightly under spec at at 9-months.
- 2024-03-13FDA-DrugEugia US LLCClass IIMethylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01
Failed Dissolution Specifications
- 2024-03-13FDA-DrugContract Pharmaceuticals Limited CanadaClass IIIClindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- 2024-03-13FDA-DrugContract Pharmaceuticals Limited CanadaClass IIIClindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- 2024-03-06FDA-DrugDenver Solutions, LLC DBA Leiters HealthClass IILidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- 2024-03-06FDA-DrugDenver Solutions, LLC DBA Leiters HealthClass IIMoxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- 2024-03-06FDA-DrugDenver Solutions, LLC DBA Leiters HealthClass IIMoxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- 2024-03-06FDA-DrugSeatex LLCClass IIPROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- 2024-03-06FDA-DrugSeatex LLCClass II7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- 2024-03-06FDA-DrugSeatex LLCClass II7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- 2024-03-06FDA-DrugSeatex LLCClass IIPROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- 2024-03-06FDA-DrugSeatex LLCClass IIPROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- 2024-03-06FDA-DrugBausch Health Companies, Inc.Class IIOmeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.
Subpotent Drug: Out of specification for assay
- 2024-03-06FDA-DrugBrassica Pharma Pvt LtdClass IILubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356
Lack of Assurance of Sterility
- 2024-03-06FDA-DrugBrassica Pharma Pvt LtdClass IICVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141
Lack of Assurance of Sterility
- 2024-03-06FDA-DrugBrassica Pharma Pvt LtdClass IIEquate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304
Lack of Assurance of Sterility
- 2024-03-06FDA-DrugBrassica Pharma Pvt LtdClass IIEquate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298
Lack of Assurance of Sterility
- 2024-03-06FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIMesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
Failed Dissolution Specifications: Out of specification for dissolution.
- 2024-03-06FDA-DrugGolden State Medical Supply Inc.Class IIFluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
- 2024-02-28FDA-DrugMicro Labs LimitedClass IIClobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01
CGMP Deviations: Out of specification for residual solvents.
- 2024-02-28FDA-DrugMCKESSON CORPORATIONClass IICABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
- 2024-02-28FDA-DrugInsight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyClass ITING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3
Chemical Contamination; presence of benzene.
- 2024-02-28FDA-DrugToday The WorldClass IArize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
- 2024-02-28FDA-DrugToday The WorldClass ISCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
- 2024-02-28FDA-DrugToday The WorldClass ISustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
- 2024-02-28FDA-DrugHenry Schein Inc. and Glove Club HSI Gloves Inc.Class IIAdrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
- 2024-02-28FDA-DrugMallinckrodt Hospital Products Inc.Class IITerlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
- 2024-02-28FDA-DrugMallinckrodt Hospital Products Inc.Class IIActhar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
- 2024-02-28FDA-DrugAscend Laboratories, LLCClass IIFosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
Failed Impurities/Degradation Specification: Out of specification for organic impurities
- 2024-02-28FDA-DrugAlpha AromaticsClass IIPure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.
CGMP Deviations
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