Browse Drug Recalls

930 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 930 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 930 FDA drug recalls in 2020.

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DateProductReasonClassFirm
Mar 24, 2020 De-Fibroidin, 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 Skin Lift 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 New Life, 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 Vertigo Off, 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 Vitiligo Off Ointment, Distributed by Herbal Doctor Remedies Alhambra, CA 918... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Pain Stopper, 500mg Capsules, 90-count bottle, 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 Fungo Lotion, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 U... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Skin De-Tag, 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-G, 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 Worm Off, 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 Metabolic Booster. 500mg Capsules, 90-count bottles, Distributed by Herbal Do... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 BioMycin, 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 Fire Off, 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 Acupuncture, 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 Fungo Off, 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 Skin Moist, 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 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 Thyro-Lo, 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 Age Back, 500 mg 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 Lump Shrinker, 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 Pain Away, 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 Tution 130, 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 Stomach Cleanser, 500mg Capsules, 90-count bottles, Distributed by Herbal Doc... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Phlegm Off, 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 Acne Cystic, 500 mg 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 Dermatoxin, 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 Herpes-G, 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 Detoxin-S, 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 Edema 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 23, 2020 Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactu... Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac... Class I Avet Pharmaceuticals, Inc.
Mar 23, 2020 Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactu... Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac... Class I Avet Pharmaceuticals, Inc.
Mar 23, 2020 Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceutical... Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule... Class III Mylan Pharmaceuticals Inc.
Mar 19, 2020 Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lot... Microbial contamination of non-sterile products: positive test for yeast and bacteria. Class II Filltech USA, LLC
Mar 19, 2020 Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor... SubPotent Drug: Low out-of-specification results for assay testing. Class II PAI Holdings, LLC. dba Pharmaceutical Associate...
Mar 19, 2020 Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml... Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for ... Class II Edge Pharma, LLC
Mar 19, 2020 Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25... Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for ... Class II Edge Pharma, LLC
Mar 19, 2020 Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lot... Microbial contamination of non-sterile products: positive test for yeast and bacteria. Class II Filltech USA, LLC
Mar 19, 2020 DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECT... Failed Stability Specifications Class II Jubilant Draximage 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 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 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 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 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 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 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 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 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 16, 2020 Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11... Defective Container: Recall is due to breaking and shattering of ampules upon opening Class I Dr. Reddy's Laboratories, Inc.
Mar 16, 2020 Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops ... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC

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.