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 18, 2013 Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Dis... Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary ... Class I SS Wholesale Inc. dba Jobbers Wholesale
Nov 18, 2013 MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterpr... Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a diet... Class I SS Wholesale Inc. dba Jobbers Wholesale
Nov 18, 2013 eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Compan... Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietar... Class I SS Wholesale Inc. dba Jobbers Wholesale
Nov 16, 2013 Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy... Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Na... Class II Tower Pharmacy and Compounding
Oct 15, 2013 Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Deliver... Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot... Class I B. Braun Medical Inc
Sep 23, 2013 Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg... Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage. Class II Watson Laboratories Inc
Sep 17, 2013 Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syring... Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefi... Class II Amgen, Inc.
Sep 13, 2013 Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles... Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sea... Class II Watson Laboratories Inc
Sep 6, 2013 Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Comp... Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ... Class II University Compounding Pharmacy
Sep 6, 2013 PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding P... Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ... Class II University Compounding Pharmacy
Sep 6, 2013 PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Ph... Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ... Class II University Compounding Pharmacy
Sep 6, 2013 Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, Universit... Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ... Class II University Compounding Pharmacy
Sep 6, 2013 Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL ... Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ... Class II University Compounding Pharmacy
Aug 30, 2013 Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 ... Defective Container: Defective bottles may not have tamper evident seals properly seated, and th... Class III Watson Laboratories Inc
Aug 26, 2013 Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Le... Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... Class II Leiter's Pharmacy
Aug 26, 2013 Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vi... Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... Class II Leiter's Pharmacy
Aug 26, 2013 Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose via... Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... Class II Leiter's Pharmacy
Aug 26, 2013 Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Co... Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... Class II Leiter's Pharmacy
Aug 23, 2013 Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vial... Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcoba... Class II South Coast Specialty Compounding, Inc.
Aug 23, 2013 Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL... Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace... Class II South Coast Specialty Compounding, Inc.
Aug 23, 2013 Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile... Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace... Class II South Coast Specialty Compounding, Inc.
Jul 19, 2013 Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhanceme... Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed ... Class I Myson Corporation, Inc.
Jul 19, 2013 Volcano Male Enhancement 1500mg, 1-count capsule packaged in a black round pl... Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed ... Class I Myson Corporation, Inc.
Jul 19, 2013 Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count... Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled... Class III Watson Laboratories Inc
Jun 20, 2013 AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infu... Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bact... Class II Gilead Sciences, Inc.
May 23, 2013 INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine... Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is... Class II Indelicare LLC
May 23, 2013 INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 m... Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is... Class II Indelicare LLC
May 8, 2013 Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopano... Class II Fusion Pharmaceuticals, LLC
May 6, 2013 Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 8... Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA anal... Class I Chang Kwung Products
May 6, 2013 Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89... Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA anal... Class I Chang Kwung Products
May 3, 2013 Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Excl... Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredi... Class II Kareway Product Inc
Apr 12, 2013 Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl... Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being reca... Class II OPMX, LLC
Apr 12, 2013 Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL... Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being reca... Class II OPMX, LLC
Apr 10, 2013 Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pil... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil,... Class I Affirm XL, Inc.
Apr 9, 2013 Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Trav... CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... Class II Total Resources Intl
Apr 9, 2013 (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: B... CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... Class II Total Resources Intl
Apr 9, 2013 3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Wa... CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... Class II Total Resources Intl
Apr 4, 2013 Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextrom... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Mar 11, 2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-... Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel parti... Class II Gsms
Mar 11, 2013 Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet ... Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil whi... Class I Green Planet Inc
Feb 22, 2013 Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intraveno... cGMP Deviation Class II Petnet Solution Inc
Feb 13, 2013 ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 ta... Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (disp... Class II Watson Laboratories Inc
Feb 8, 2013 Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Wat... Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate ... Class II Watson Laboratories Inc
Feb 8, 2013 Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Wat... Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate ... Class II Watson Laboratories Inc
Jan 31, 2013 Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx on... Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir ... Class I Gilead Sciences, Inc.
Jan 18, 2013 Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Jan 18, 2013 Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextro... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Jan 18, 2013 Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextro... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Jan 18, 2013 Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorp... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Jan 16, 2013 Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use ... Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point. Class III Actelion Pharmaceuticals U.S., 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.