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.

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DateProductReasonClassFirm
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
Mar 24, 2020 Fungo Balm, 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 Herpes-P, 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 Cellulite Off, 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 Hernia 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 Nasal Ez, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Reme... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Herpes V Balm, 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 Blood Clot Purger, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Skin Lift, 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 Sperm Booster, 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 Herpes Soap, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 US... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Age Stop Ex, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 US... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Asma Stopper, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor ... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Sugar Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Rem... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Herpes V Balm, 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 Skin Cleanser, 500mg Capsules, 90-count bottles2, Distributed by Herbal Docto... 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.