Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 24, 2020 | Voice Rescue, 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 | Flare 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 | Reman-AP, 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 | Reman-8, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remed... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Lupus Care, 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 | PC Shrinker, 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 | Thyro-H, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remed... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Lipidtrol, 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 | DeTensin 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 | Reman-6, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remed... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Asthma Chest Rub, 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 | Immune-2100, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor R... | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Class II | Herbal Doctor Remedies |
| Mar 24, 2020 | Sweat Oil, 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 | 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 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 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 | 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 | 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 | 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 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. |
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.