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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.