FDA Recall
Ongoing
Historical recordClass II
Fluticasone 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
by Golden State Medical Supply Inc.
- Reason
- CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- The recalled Reser's Amish Macaroni Salad was packaged in a…
- Reason
- Undeclared Wheat. The recalled Reser's Amish Macaroni Salad was packaged in a plastic container where the top lid is correctly labeled as Reser s Amish Macaroni Salad but the container side label mis-labeled as Reser s Southern Style with Egg Potato Salad. The ingredient statement on the Reser s Southern Style with Egg Potato Salad container side label does not declare wheat.
- Published
- March 6, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Clobazam 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
by Micro Labs Limited
- Reason
- CGMP Deviations: Out of specification for residual solvents.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CABTREO (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.
by MCKESSON CORPORATION
- Reason
- CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
- Published
- February 28, 2024
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass I
TING 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
by Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
- Reason
- Chemical Contamination; presence of benzene.
- Published
- February 28, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
by Today The World
- Reason
- 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.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
by Today The World
- Reason
- 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.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
by Today The World
- Reason
- 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.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Adrenalin (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
by Henry Schein Inc. and Glove Club HSI Gloves Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
- Published
- February 28, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Terlivaz (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
by Mallinckrodt Hospital Products Inc.
- Reason
- cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Acthar 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
by Mallinckrodt Hospital Products Inc.
- Reason
- cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Fosfomycin 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
by Ascend Laboratories, LLC
- Reason
- Failed Impurities/Degradation Specification: Out of specification for organic impurities
- Published
- February 28, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20
by Baxter Healthcare Corporation
- Reason
- Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
- Published
- February 28, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
by Neptune Resources, LLC
- Reason
- Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
by Neptune Resources, LLC
- Reason
- Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
by Neptune Resources, LLC
- Reason
- Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
by Bestco LLC
- Reason
- CGMP Deviations: Potential Glass and Silicone particulates in product
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
by Bestco LLC
- Reason
- CGMP Deviations: Potential Glass and Silicone particulates in product
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
by Bestco LLC
- Reason
- CGMP Deviations: Potential Glass and Silicone particulates in product
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
by Bestco LLC
- Reason
- CGMP Deviations: Potential Glass and Silicone particulates in product
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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