Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 6, 2020 | Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar, Rx, The Medicine Shopp... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Progesterone/Versa Base 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe ... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Levothyroxin (T4)/Liothyronine (T3) SR 130 mg/175 mg capsule 21 capsules bott... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar, Rx, The Medicine Shoppe P... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (8:2)/Progesterone/Testosterone 0.5/75 mg per 0.2 mL Cream 6 mL jar, R... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharma... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Testosterone w/ Atrevis 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe ... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (50/50/Progesterone 0.2 mg/70 mg Cream 30 gm jar, Rx, The Medicine Sho... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM, tube Rx, T... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (8:2)/Progest/Test/DHEA 6/50/0.5/10 mg/mL Cream 30 mL, Rx, The Medicin... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Testosterone in Atrevis 75 mg/mL Gel 90 GMS tube, Rx, The Medicine Shoppe Pha... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Estradiol 1.8 mg capsule 30 cap bottle, Rx, The Medicine Shoppe Pharmacy, Por... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (1:1) Progesterone/Testost 1.0 mg/60 mg/0.5 mg/mL Cream 60 gm tube, Rx... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est 1:1/Progest/DHEA 1/40/5 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est 8:2/Progesterone/Testosterone DHEA 4.0/100/1/25.0 mg capsules 90 capsu... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream 100 gm tube, Rx, Th... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est 1:1/Progesterone/Testosterone 2.0/100/0.25 mg/mL Cream 30 gm tube, Rx,... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tub... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Hydromorphone Oral 1 mg/mL Solution 240 mL, bottle, Rx, The Medicine Shoppe P... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (8:2) Progest/Test 2/80/3 mg/mL cream 30 gm tube, Rx, The Medicine Sho... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (8:2)/DHEA/Testosterone 0.8 mg/ 9/0.4 mg/0.2 mg/mL Cream 6 gm tube, Rx... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository (Pink) 48 supposi... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Ergotamine Tartrate 1 mg/Caffeine 100 mg Base Suppository (Pink) 48 count box... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL Cream 30 gm tube, Rx, ... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est 1:1/Progesterone/Testosterone 1mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar, Rx, The Medici... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 3, 2020 | Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30)... | CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active i... | Class II | Golden State Medical Supply Inc. |
| 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 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per car... | Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.... | Class III | Akorn Inc |
| 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 |
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.