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