Browse Drug Recalls

3,394 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,394 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 3,394 FDA drug recalls.

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DateProductReasonClassFirm
Mar 24, 2020 Vigo-XXX, 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 Dermamycin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Re... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-70... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Purple Gold Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-70... 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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 18, 2020 Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aur... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Auro... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 13, 2020 Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by:... CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Prac... Class II Sun Pharmaceutical Industries, Inc.
Mar 13, 2020 Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by:... CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Prac... Class II Sun Pharmaceutical Industries, Inc.
Mar 11, 2020 Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx ... CGMP Deviations: Presence of dark brown discoloration on edges of tablets Class II Jubilant Cadista Pharmaceuticals, Inc.
Mar 6, 2020 Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, ... CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/... Class II Nostrum Laboratories Inc
Mar 5, 2020 Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: ... CGMP Deviation: Chemical indicators were not positioned properly during sterilization process. Class II Fresenius Medical Care Holdings, Inc.
Mar 5, 2020 Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled ... CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-market... Class II Teva Pharmaceuticals USA
Feb 28, 2020 Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, ... cGMP Deviation Class II Sunstar Guangzhou Ltd.
Jan 31, 2020 Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, ... cGMP Deviations Class II Zydus Pharmaceuticals USA Inc
Jan 27, 2020 Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-c... CGMP deviations: Product bottle may be absent of desiccant. Class II Teva Pharmaceuticals USA
Jan 27, 2020 Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-c... CGMP deviations: Product bottle may be absent of desiccant. Class II Teva Pharmaceuticals USA
Jan 24, 2020 Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactu... cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API sour... Class II Ascend Laboratories LLC
Jan 24, 2020 Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51... CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin ... Class II Breckenridge Pharmaceutical, Inc
Jan 24, 2020 Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 5199... CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin ... Class II Breckenridge Pharmaceutical, Inc
Jan 15, 2020 Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Dir... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Direct Rx
Jan 15, 2020 Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-3... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Direct Rx
Jan 14, 2020 Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL ... cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a prev... Class II Sun Pharmaceutical Industries, Inc.
Jan 14, 2020 Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp.,... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Spectrum Laboratory Products
Jan 14, 2020 Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Sin... cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a prev... Class II Sun Pharmaceutical Industries, Inc.
Jan 10, 2020 Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.0... CGMP Deviations: Out of specification test result observed during retrospective review of blend u... Class III Lupin Pharmaceuticals 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.