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.

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DateProductReasonClassFirm
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.
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

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.