Browse Drug Recalls

557 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 557 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 557 FDA drug recalls in 2024.

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DateProductReasonClassFirm
Feb 2, 2024 Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This pac... Subpotent Drug: Out of specification for assay Class II Bausch Health Companies, Inc.
Feb 1, 2024 To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing ... Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. Class I Integrity Products
Feb 1, 2024 HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit d... Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged... Class III Amerisource Health Services LLC
Feb 1, 2024 RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a ... Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. Class I Integrity Products
Feb 1, 2024 TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 o... Chemical Contamination; presence of benzene. Class I Insight Pharmaceuticals LLC, a Prestige Consume...
Feb 1, 2024 Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactur... CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on ... Class II NATCO Pharma Limited
Jan 30, 2024 Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%... Lack of Assurance of Sterility Class II Brassica Pharma Pvt Ltd
Jan 30, 2024 Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Package... Lack of Assurance of Sterility Class II Brassica Pharma Pvt Ltd
Jan 30, 2024 CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrol... Lack of Assurance of Sterility Class II Brassica Pharma Pvt Ltd
Jan 30, 2024 Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Pa... Lack of Assurance of Sterility Class II Brassica Pharma Pvt Ltd
Jan 25, 2024 Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic reg... Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. Class III Teva Pharmaceuticals USA, Inc
Jan 25, 2024 Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent Internat... CGMP Deviations Class II Alpha Aromatics
Jan 25, 2024 Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distribut... CGMP Deviations Class II Amerisource Health Services LLC
Jan 25, 2024 Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in... Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. Class III Teva Pharmaceuticals USA, Inc
Jan 23, 2024 Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL),... Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified ... Class II Baxter Healthcare Corporation
Jan 22, 2024 Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injectio... Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyon... Class II IntegraDose Compounding Services LLC
Jan 19, 2024 Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic,... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 19, 2024 Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS CGMP Deviations Class II OMEZA LLC
Jan 19, 2024 Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials CGMP Deviations Class II OMEZA LLC
Jan 19, 2024 Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 d... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 19, 2024 Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 19, 2024 Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 19, 2024 CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 18, 2024 Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hou... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy'... Misprint on tablet Class III Dr. Reddy's Laboratories, Inc.
Jan 18, 2024 Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, D... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distr... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablet... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy'... Misprint on tablet Class III Dr. Reddy's Laboratories, Inc.
Jan 18, 2024 Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distri... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 17, 2024 Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Pack... Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouc... Class II Henry Schein Inc. and Glove Club HSI Gloves Inc.
Jan 16, 2024 Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of... Failed Impurities/Degradation Specification: Out of specification for organic impurities Class II Ascend Laboratories, LLC
Jan 16, 2024 OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcoh... CGMP Deviations: products may not conform to the labeled specifications. Class II Den-Mat Holdings, LLC
Jan 16, 2024 Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flav... CGMP Deviations: products may not conform to the labeled specifications. Class II Den-Mat Holdings, LLC
Jan 15, 2024 Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only,... Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. Class II Amneal Pharmaceuticals of New York, LLC
Jan 12, 2024 Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 7... Subpotent Drug Class II IntegraDose Compounding Services LLC
Jan 12, 2024 Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Di... Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... Class I Neptune Resources, LLC
Jan 12, 2024 Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, ... Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... Class I Neptune Resources, LLC
Jan 12, 2024 Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wi... Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... Class I Neptune Resources, LLC
Jan 12, 2024 Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Markete... Failed Dissolution Specifications Class II Golden State Medical Supply Inc.
Jan 11, 2024 Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx... Failed Impurities/Degradation Specification. Class II Amerisource Health Services LLC
Jan 11, 2024 Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 u... Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper speci... Class II Par Sterile Products LLC
Jan 10, 2024 Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for I... Lack of Sterility Assurance: Aseptic process simulation failure. Class II BE PHARMACEUTICALS AG
Jan 10, 2024 Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Parabe... Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while t... Class II MEDLINE INDUSTRIES, LP - Northfield

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.