Browse Drug Recalls

1,091 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,091 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 1,091 FDA drug recalls in CA.

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DateProductReasonClassFirm
Nov 22, 2024 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your R... CGMP Deviations: Inconsistency in the water systems. Class II Generitech Corporation
Nov 4, 2024 ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomM... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... Class I Boulla LLC
Nov 4, 2024 PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distribut... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... Class I Boulla LLC
Nov 4, 2024 VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Dist... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... Class I Boulla LLC
Nov 4, 2024 ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... Class I Boulla LLC
Oct 8, 2024 AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg, Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... Class II C & A Naturistics
Sep 24, 2024 Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Ma... Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in... Class II Nivagen Pharmaceuticals Inc
Sep 19, 2024 Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... Presence of Particulate Matter: Presence of glass particle. Class I Gilead Sciences, Inc.
Sep 18, 2024 Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sd... Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone ... Class I 123Herbals
Aug 28, 2024 BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML... Microbial contamination of non-sterile Products - Class II PREQUEL SKIN
Aug 8, 2024 Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bo... Failed Impurities/Degradation Specifications - at 18-month Stability testing Class II Preferred Pharmaceuticals, Inc.
Jul 24, 2024 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Brau... Presence of Particulate Matter Class I B. Braun Medical Inc
Jul 18, 2024 Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in ... Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Dicl... Class I MAIN PRODUCTS INC
Jul 12, 2024 Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in ... Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared D... Class I SoloVital
Jun 24, 2024 SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, ... Sub-potent Drug Class III Neilmed Pharmaceuticals Inc
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
May 22, 2024 OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 3... Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undec... Class II MexHealth LLC
May 20, 2024 Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San F... Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo ... Class II Genentech, Inc.
May 13, 2024 Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottl... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... Class II Golden State Medical Supply Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Rel... Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on ... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), ... Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred ... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Preferred Pharmaceuticals, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed),... Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixe... Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixe... Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 7, 2024 Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectab... Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C. Class II PACIRA PHARMACEUTICALS INC
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 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 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
Feb 14, 2024 Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays,... CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex Class II Golden State Medical Supply Inc.
Feb 9, 2024 Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076... Failed Dissolution Specifications: results slightly under spec at at 9-months. Class III Stason Pharmaceuticals, Inc.
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 12, 2024 Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Markete... Failed Dissolution Specifications Class II Golden State Medical Supply Inc.
Dec 13, 2023 Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-C... CGMP Deviations: Stability data does not support expiry date. Class II Private Label Partners, Inc.
Nov 13, 2023 KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Sus... Failed Impurities/Degradation Specifications Class II KINDER FARMS LLC
Nov 13, 2023 KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral ... Failed Impurities/Degradation Specifications Class II KINDER FARMS LLC
Nov 10, 2023 PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-... Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... Class II Golden State Medical Supply Inc.
Nov 10, 2023 PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-73... Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... Class II Golden State Medical Supply Inc.
Nov 10, 2023 PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-73... Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... Class II Golden State Medical Supply 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.