Browse Drug Recalls

3,458 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,458 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 3,458 FDA drug recalls.

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DateProductReasonClassFirm
Jul 26, 2019 Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 7... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochlorid... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each displa... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 18, 2019 Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg ... CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufactur... Class II Preferred Pharmaceuticals, Inc
Jul 16, 2019 Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07)... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 15, 2019 DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistami... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Jul 15, 2019 CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Jul 15, 2019 CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moi... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Jul 12, 2019 Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Edema Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Fungo Off Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Lung Tonic EX Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Detensin, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Smoke End Capsules,Distributed Herbal Doctor Remedies Alhambra, CA 91801-7081... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Stomach Flu Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 9180... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Herpes-V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Worm Off, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Dragon Pain Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-708... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Herpes-S, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Baby Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Asma Stopper Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Anemia Off, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 US... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Lung Fixer Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Herpes-G Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Hair Back, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Asthma Balm 60 gram, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Yeast Douche Powder, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Psoriasis Balm, 60 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, ... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Vertigo Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 9180... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Lube Lax Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Sperm Booster, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Asma Aid Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Cardia Forte, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alham... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Lung Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-70... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Fungo Balm, 30 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(80... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Deafness Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 918... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Herpes-P, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Thyro-H, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, ... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Lipidtrol Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Mental Tonic Capsules, Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Pain Away, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Re... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Thyro-Lo, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Bone Fixer, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Lump Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... 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.