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 |
|---|---|---|---|---|
| May 18, 2015 | SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, ... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced ... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compo... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced C... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Ph... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compo... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advan... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Adv... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE,... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Co... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Adv... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| Apr 23, 2015 | Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Comp... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) cap... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, ... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufac... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park ... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manu... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,00... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving,... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufa... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvin... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufa... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 10, 2015 | ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe... | Failed pH specification | Class III | Oasis Medical, Inc. |
| Mar 6, 2015 | DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) Fuse... | Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia... | Class II | Fusion Pharmaceuticals, LLC |
| Jan 6, 2015 | Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags,... | Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or... | Class I | Wallcur Incorporated |
| Dec 4, 2014 | Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline H... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the C... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povid... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (1... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| 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. |
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.