Browse Drug Recalls
1,076 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,076 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 1,076 FDA drug recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 22, 2014 | Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) ... | Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... | Class II | Prometheus Laboratories Inc. |
| Oct 17, 2014 | Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinon... | Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadverten... | Class II | Obagi Medical Products |
| Oct 7, 2014 | ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ... | Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listin... | Class II | Zee Medical Products Inc |
| Oct 1, 2014 | Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Man... | Defective Container; leaking around the cap | Class II | Gilead Sciences, Inc. |
| Sep 30, 2014 | Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) table... | Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates. | Class III | Gilead Sciences, Inc. |
| Jul 18, 2014 | Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP... | CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. | Class II | Spectrum Laboratory Products |
| Jun 24, 2014 | Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 7... | Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this... | Class II | Doctor's Best, Inc. |
| May 22, 2014 | Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex P... | Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofl... | Class II | Aidarex Pharmaceuticals LLC |
| May 14, 2014 | Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distribu... | Labeling: Missing Label; The label on the immediate bottle is missing. | Class III | Oasis Medical Inc |
| Apr 30, 2014 | Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boost... | Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Li... | Class I | Bacai Inc. Dba Ky Duyen House |
| Apr 15, 2014 | Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured f... | Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and ... | Class I | Sung Soo Kim |
| Apr 15, 2014 | Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl an... | Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. | Class III | P&L Developments, LLC |
| Apr 14, 2014 | Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorph... | Subpotent Drug: Phenylephrine component is subpotent. | Class III | P&L Developments, LLC |
| Apr 14, 2014 | LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactur... | Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning | Class II | Golden State Medical Supply Inc. |
| Apr 11, 2014 | Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dex... | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... | Class III | Aaron Industries Inc |
| Feb 19, 2014 | Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarat... | Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug. | Class III | Gilead Sciences, Inc. |
| 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 |
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.