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 |
|---|---|---|---|---|
| Apr 1, 2020 | Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: L... | Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopr... | Class II | Lupin Pharmaceuticals Inc. |
| Mar 31, 2020 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... | Defective Delivery System: Out of specification for mechanical peel and shear. | Class II | Noven Therapeutics, LLC |
| Mar 31, 2020 | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.... | Defective Delivery System: Out of specification for mechanical peel and shear. | Class II | Noven Therapeutics, LLC |
| Mar 31, 2020 | Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.... | Defective Delivery System: Out of specification for mechanical peel and shear. | Class II | Noven Therapeutics, LLC |
| Mar 30, 2020 | Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Ph... | Failed Impurities/Degradation Specification: Presence of unknown impurity observed. | Class II | Par Pharmaceutical Inc. |
| Mar 26, 2020 | Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INN... | Lack of Assurance of Sterility | Class II | Innovative Intrathecal Solutions, Inc. dba Inno... |
| Mar 26, 2020 | Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Avet Pharmaceuticals, Inc. |
| Mar 26, 2020 | MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, ... | Lack of Assurance of Sterility | Class II | Innovative Intrathecal Solutions, Inc. dba Inno... |
| Mar 26, 2020 | Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 c... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Avet Pharmaceuticals, Inc. |
| Mar 26, 2020 | Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE CO... | Lack of Assurance of Sterility | Class II | Innovative Intrathecal Solutions, Inc. dba Inno... |
| Mar 26, 2020 | Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injecta... | Lack of Assurance of Sterility | Class II | Innovative Intrathecal Solutions, Inc. dba Inno... |
| Mar 26, 2020 | Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INN... | Lack of Assurance of Sterility | Class II | Innovative Intrathecal Solutions, Inc. dba Inno... |
| Mar 25, 2020 | LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturi... | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Teva Pharmaceuticals USA |
| Mar 25, 2020 | LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufactur... | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Teva Pharmaceuticals USA |
| Mar 25, 2020 | LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufactur... | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Teva Pharmaceuticals USA |
| 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Max Slim, 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 | Hair Back Lotion, 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 | Detoxin Ex, 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 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 | Hair Back Ex, 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 | 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 |
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.