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
Apr 17, 2024 Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 12, 2024 Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jar... cGMP Deviations Class II Dercher Enterprises, Inc., DBA Gordon Laboratories
Apr 10, 2024 Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL S... Out of specification for assay Class III Imprimis NJOF, LLC
Apr 10, 2024 Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solut... Subpotent Drug Class II Imprimis NJOF, LLC
Apr 9, 2024 Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only,... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 5... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, ... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only,... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 8, 2024 Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 ind... Sub-potent Drug; powder discoloration associated with decreased potency Class I Dr. Reddy's Laboratories, Inc.
Apr 8, 2024 Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual pac... Sub-potent Drug; powder discoloration associated with decreased potency Class I Dr. Reddy's Laboratories, Inc.
Apr 2, 2024 Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent... Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... Class III X-Gen Pharmaceuticals Inc.
Apr 2, 2024 Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, ... Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... Class III X-Gen Pharmaceuticals Inc.
Mar 29, 2024 Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents:... CGMP Deviations Class II HONEYWELL INC
Mar 28, 2024 Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx O... Superpotent Drug: The 3-month stability result for assay was found to be above specification limit Class II Teva Pharmaceuticals USA, Inc
Mar 28, 2024 Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cart... Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. Class I AvKARE
Mar 27, 2024 NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottl... Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month... Class III Esperion
Mar 27, 2024 Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treat... CGMP Deviations Class II NATCO Pharma Limited
Mar 26, 2024 Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution... Class II Glenmark Pharmaceuticals Inc., USA
Mar 26, 2024 Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3... Short fill: Complaints received of less fill volume in respule and few drops of liquid observed i... Class II Cipla USA, Inc.
Mar 25, 2024 Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufa... Failed Impurities/Degradation Specifications Class III Novitium Pharma LLC
Mar 25, 2024 Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distr... Failed Dissolution Specifications Class II Amneal Pharmaceuticals of New York, LLC
Mar 23, 2024 Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle,... Chemical Contamination: Product manufactured with ethanol API that contains methanol Class I Aruba Aloe Balm N.V.
Mar 23, 2024 Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in... Chemical Contamination: Product manufactured with ethanol API that contains methanol Class I Aruba Aloe Balm N.V.
Mar 22, 2024 Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Me... Lack of assurance of sterility: bags have the potential to leak.. Class II B. Braun Medical Inc
Mar 22, 2024 fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, I... Lack of Assurance of Sterility: leaking bags Class II IntegraDose Compounding Services LLC
Mar 21, 2024 Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as... Superpotent Drug: Due to overfilling of drug powder Class I Amneal Pharmaceuticals of New York, LLC
Mar 21, 2024 Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lu... Subpotent Drug Class II Lupin Pharmaceuticals Inc.
Mar 21, 2024 VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9... cGMP Diviations Class II Apothecus Pharmaceutical Corp.
Mar 19, 2024 GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A. Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres L... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 SILVERBACK 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 tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 HONEY 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 tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving ... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Samurai-X Honey 6800, UPC 2 56891 27553 3. Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455 Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557 Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Flower 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 tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Weiner Boner Honey, 12g packet, 100% Organic Formula. Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 12, 2024 Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul,... The filter included in the carton has an expiration date that has expired prior to the expiration... Class II Hikma Pharmaceuticals USA Inc.
Mar 12, 2024 Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 RE... CGMP Deviations Class II Eli Lilly & Company
Mar 7, 2024 Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic ... Failed Dissolution Specifications Class II Teva Pharmaceuticals USA, Inc
Mar 6, 2024 Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), ... Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, spec... Class II B. Braun Medical Inc
Mar 5, 2024 Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactu... Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. Class II Thea Pharma, Inc.
Mar 4, 2024 Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufact... Cross Contamination with Other Products:(mycophenolate mofetil). Class III Novitium Pharma LLC
Mar 4, 2024 Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 4, 2024 Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 4, 2024 Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenou... Presence of Particulate Matter. Class I Par Sterile Products LLC
Mar 1, 2024 S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or R... Failed Stability Specifications Class II Specialty Process Labs LLC

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.