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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.