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
Jul 12, 2024 Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199 Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared ... Class I Supercore Products Group Inc.
Jul 11, 2024 Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 ... Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the ... Class I Aurobindo Pharma USA Inc
Jul 10, 2024 Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per ... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg ins... Class I Endo Pharmaceuticals, Inc.
Jul 9, 2024 Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules p... Failed Dissolution Specifications Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 8, 2024 Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose b... Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found ... Class I Hikma Pharmaceuticals USA Inc.
Jul 3, 2024 Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:20... Subpotent Drug: reduced efficacy for epinephrine Class II TAILSTORM HEALTH INC
Jul 2, 2024 Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... Cross contamination with other products Class III Zydus Pharmaceuticals (USA) Inc
Jul 2, 2024 Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotox... CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltere... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 2, 2024 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorba... Defective container: potential for non-sealed pouches which can lead to product leakage. Class III Novel Laboratories, Inc. d.b.a Lupin Somerset
Jul 2, 2024 Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... Cross contamination with other products Class III Zydus Pharmaceuticals (USA) Inc
Jul 2, 2024 Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Singl... Cross contamination with other products. Class III Zydus Pharmaceuticals (USA) Inc
Jul 2, 2024 Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a)... Cross contamination with other products. Class III Zydus Pharmaceuticals (USA) Inc
Jun 28, 2024 Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 684... Failed Dissolution Specifications: results below specifications Class II Glenmark Pharmaceuticals Inc., USA
Jun 28, 2024 Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, ... Failed Impurities/Degradation Specifications: Product is being recalled due to API related substa... Class II Teva Pharmaceuticals USA, Inc
Jun 27, 2024 Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only,... Presence of particulate matter: glass Class II Zydus Pharmaceuticals (USA) Inc
Jun 26, 2024 Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets ... Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on pa... Class III Dr. Reddy's Laboratories, Inc.
Jun 26, 2024 Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 6... Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared a... Class II Guru Inc.
Jun 26, 2024 Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML... CGMP Deviations: Manufactured without following Current Good Manufacturing Practises. Class II Equibal Inc
Jun 26, 2024 Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystallin... CGMP Deviations and Presence of Particulate Matter: Glass Class II Medisca Inc.
Jun 26, 2024 Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count... CGMP Deviations: Out of specification for dissolution Class II RemedyRepack Inc.
Jun 25, 2024 Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by:... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed b... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz ... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-... Failed Dissolution Specifications Class I Amerisource Health Services LLC
Jun 24, 2024 SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, ... Sub-potent Drug Class III Neilmed Pharmaceuticals Inc
Jun 24, 2024 Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne ... Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testin... Class III Rising Pharma Holding, Inc.
Jun 24, 2024 buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg,... Failed Dissolution Specifications; the product is dissolving faster than the specified limits. Class II Amerisource Health Services LLC
Jun 21, 2024 Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Package... Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrec... Class I A-S Medication Solutions LLC
Jun 21, 2024 Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in ... Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing ... Class II Zydus Pharmaceuticals (USA) Inc
Jun 20, 2024 Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) pa... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as ... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Package... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) P... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packag... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UP... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL ... CGMP deviations Class II Little Moon Essentials LLC
Jun 18, 2024 DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% D... This product is being recalled due to the tube weld failure presents itself as a slow leak and ca... Class II Fresenius Medical Care Holdings, Inc.
Jun 18, 2024 Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 bl... Failed dissolution specifications: out of specification result obtained during routine stability ... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jun 18, 2024 Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple do... Subpotent drug: out of specification results Class III Accord Healthcare, Inc.
Jun 17, 2024 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assemb... Class II Baxter Healthcare Corporation
Jun 17, 2024 Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count... Failed dissolution specifications: this product is being recalled due to this batch not meeting d... Class II Trigen Laboratories
Jun 12, 2024 Zilretta (triamcinolone acetonide extended-release injectable suspension), 32... Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing... Class II PACIRA PHARMACEUTICALS INC
Jun 10, 2024 Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), p... Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination Class II Brands International Corporation
Jun 7, 2024 Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured... Presence of foreign substance. Class II Dr. Reddy's Laboratories, Inc.
Jun 5, 2024 STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distri... Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms Class I Homeocare Laboratories, Inc.
Jun 5, 2024 STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473... Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism Class II Homeocare Laboratories, Inc.
Jun 4, 2024 Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-co... Subpotent Drug Class II Teva Pharmaceuticals USA, Inc
Jun 4, 2024 Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Redd... Failed Impurities/Degradation Specifications: Related Substances Class III Dr. Reddy's Laboratories, Inc.

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.