Browse Drug Recalls

1,110 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,110 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 1,110 FDA drug recalls in CA.

Clear
DateProductReasonClassFirm
Feb 4, 2014 Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan ... Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenes... Class III Aaron Industries Inc
Jan 15, 2014 Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 10... Failed Tablet/Capsule Specifications; Product contains broken tablets. Class II Watson Laboratories Inc
Jan 13, 2014 PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distribute... Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, N... Class I HUMAN SCIENCE FOUNDATION
Dec 23, 2013 Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactur... Presence of Foreign Substance; metal particulates were visually observed in the tablets. Class II Watson Laboratories Inc
Nov 27, 2013 0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Bra... Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 ... Class II B. Braun Medical Inc
Nov 21, 2013 Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Conta... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, C... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No.... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB C... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 m... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Containe... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 19, 2013 NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack... Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared activ... Class I Tendex
Nov 19, 2013 P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack ... Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared activ... Class I Tendex
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

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.