Drug and pharmaceutical recalls
17658 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2024-05-01FDA-DrugNomax IncClass IIGloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
- 2024-05-01FDA-DrugNomax IncClass IIGloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
- 2024-05-01FDA-DrugHONEYWELL INCClass IIEyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37
CGMP Deviations
- 2024-05-01FDA-DrugAruba Aloe Balm N.V.Class IAruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5
Chemical Contamination: Product manufactured with ethanol API that contains methanol
- 2024-05-01FDA-DrugAruba Aloe Balm N.V.Class IAlcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean.
Chemical Contamination: Product manufactured with ethanol API that contains methanol
- 2024-05-01FDA-DrugPyramids Wholesale Inc.Class IHONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- 2024-05-01FDA-DrugPyramids Wholesale Inc.Class IALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- 2024-05-01FDA-DrugPyramids Wholesale Inc.Class IThe GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- 2024-05-01FDA-DrugPyramids Wholesale Inc.Class ISILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- 2024-05-01FDA-DrugPyramids Wholesale Inc.Class Ilibigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- 2024-05-01FDA-DrugPyramids Wholesale Inc.Class IGoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- 2024-05-01FDA-DrugPyramids Wholesale Inc.Class IPink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- 2024-05-01FDA-DrugPyramids Wholesale Inc.Class ISamurai-X Honey 6800, UPC 2 56891 27553 3.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- 2024-05-01FDA-DrugPyramids Wholesale Inc.Class IFlower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- 2024-05-01FDA-DrugPyramids Wholesale Inc.Class IWeiner Boner Honey, 12g packet, 100% Organic Formula.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- 2024-05-01FDA-DrugPyramids Wholesale Inc.Class ISpanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- 2024-04-24FDA-DrugSpecialty Process Labs LLCClass IIS.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03
Failed Stability Specifications
- 2024-04-24FDA-DrugSpecialty Process Labs LLCClass IIS.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
Failed Stability Specifications
- 2024-04-24FDA-DrugEli Lilly & CompanyClass IISterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01
CGMP Deviations
- 2024-04-24FDA-DrugAvKAREClass IAtovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
- 2024-04-24FDA-DrugNovitium Pharma LLCClass IIIDigoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10
Failed Impurities/Degradation Specifications
- 2024-04-24FDA-DrugAmneal Pharmaceuticals of New York, LLCClass IVancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Superpotent Drug: Due to overfilling of drug powder
- 2024-04-24FDA-DrugEsperionClass IIINEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
- 2024-04-17FDA-DrugEugia US LLCClass IMethocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10
Presence of Particulate Matter
- 2024-04-17FDA-DrugTeva Pharmaceuticals USA, IncClass IIIsotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
- 2024-04-17FDA-DrugNATCO Pharma LimitedClass IILansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
CGMP Deviations
- 2024-04-17FDA-DrugLupin Pharmaceuticals Inc.Class IIRifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06
Subpotent Drug
- 2024-04-10FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IIFentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1
Lack of Assurance of Sterility: Firm did not perform process validation.
- 2024-04-10FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IIPhenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1
Lack of Assurance of Sterility: Firm did not perform process validation.
- 2024-04-10FDA-DrugX-Gen Pharmaceuticals Inc.Class IIICyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
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