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
Oct 26, 2021 artnaturals Hand Sanitizer CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as t... Class II VIRGIN SCENT INC
Oct 26, 2021 artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), ... CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as t... Class II VIRGIN SCENT INC
Oct 14, 2021 Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, M... Failed Excipient Specification; product manufactured using an excipient found to be OOS for condu... Class II Golden State Medical Supply Inc.
Oct 14, 2021 Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets,... Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured us... Class II Golden State Medical Supply Inc.
Oct 12, 2021 Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60... Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actua... Class I Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sep 28, 2021 Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC... Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... Class III Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sep 28, 2021 Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC:... Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... Class III Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sep 21, 2021 Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chl... CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or ... Class II Sanitor Corporation
Aug 2, 2021 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE IN... Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... Class I Je Dois Lavoir LLC
Jul 30, 2021 FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, R... Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmen... Class II Custopharm, Inc.
Jul 14, 2021 Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 4... Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. Class I Qikmoov LLC
Jun 22, 2021 QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, M... Subpotent Class II HOYU(US) LOGISTICS INC
Jun 9, 2021 Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For... Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content we... Class II Genentech Inc
May 11, 2021 Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beau... Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ing... Class II DASH XCLUSIVE
Apr 28, 2021 Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 ... CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily In... Class II Preferred Pharmaceuticals, Inc.
Apr 20, 2021 Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total vo... Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA)... Class III Genentech Inc
Apr 12, 2021 Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Susp... Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detec... Class II Preferred Pharmaceuticals, Inc.
Mar 19, 2021 Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only,... Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown i... Class II Golden State Medical Supply Inc.
Mar 19, 2021 Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Bli... Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed ... Class III Asclemed USA Inc. dba Enovachem Pharmaceuticals
Jan 27, 2021 Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 636... Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolact... Class I Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Jan 27, 2021 Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Ma... Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolact... Class II Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Jan 6, 2021 Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ F... Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly place... Class II DLC Laboratories, Inc
Dec 17, 2020 ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (4... Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast Class I NDAL Mfg Inc.
Nov 17, 2020 ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, M... FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits f... Class II Golden State Medical Supply Inc.
Nov 1, 2020 Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage X... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acce... Class II Preferred Pharmaceuticals, Inc.
Oct 9, 2020 N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bo... Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap. Class II Jarrow Formulas Inc
Oct 1, 2020 Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL),... Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleadin... Class I ASHTEL STUDIOS, INC.
Sep 2, 2020 Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyr... CGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Sep 2, 2020 Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyr... CGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Sep 2, 2020 Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyron... CGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Sep 2, 2020 Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) ... CGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Jul 27, 2020 Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (20... cGMP deviations Class II RESOURCE RECOVERY & TRADING LLC
Jul 27, 2020 HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.... cGMP deviations Class II RESOURCE RECOVERY & TRADING LLC
Jul 24, 2020 Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-9... Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ... Class III Golden State Medical Supply Inc.
Jul 6, 2020 Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distr... SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. Class III Allergan PLC
Jul 6, 2020 Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0... SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. Class III Allergan PLC
Jul 1, 2020 Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% to... CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test ... Class II Preferred Pharmaceuticals, Inc.
Jun 22, 2020 Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distr... Chemical Contamination: Product contains undeclared methanol. Class I UVT INC
Jun 17, 2020 Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage X... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acce... Class II Preferred Pharmaceuticals, Inc.
Apr 18, 2020 Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Dupl... Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Pol... Class I B. Braun Medical Inc
Apr 15, 2020 Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-coun... cGMP Deviations Class II H J Harkins Company Inc dba Pharma Pac
Apr 3, 2020 Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30)... CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active i... Class II Golden State Medical Supply Inc.
Mar 26, 2020 Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INN... Lack of Assurance of Sterility Class II Innovative Intrathecal Solutions, Inc. dba Inno...
Mar 26, 2020 Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injecta... Lack of Assurance of Sterility Class II Innovative Intrathecal Solutions, Inc. dba Inno...
Mar 26, 2020 Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE CO... Lack of Assurance of Sterility Class II Innovative Intrathecal Solutions, Inc. dba Inno...
Mar 26, 2020 MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, ... Lack of Assurance of Sterility Class II Innovative Intrathecal Solutions, Inc. dba Inno...
Mar 26, 2020 Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INN... Lack of Assurance of Sterility Class II Innovative Intrathecal Solutions, Inc. dba Inno...
Mar 24, 2020 Bleeding Stop, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Acne Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Pimples Off Solution 60 ML, Distributed by Herbal Doctor Remedies Alhambra, C... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies

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.