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 |
|---|---|---|---|---|
| Apr 6, 2020 | Naltrexone 4.5 mg/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmac... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Diethylstilbestrol 1 mg capsule 300 capsules bottle, Rx, The Medicine Shoppe ... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (50/50)/Progesterone/Testosterone 1.5 mg/40 mg/0.5 mg/mL Cream 30 gm t... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (1:1) Progest/Test 0.5 mg/1.5 mg/mL cream 60 gm tube, Rx, The Medicine... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Testosterone w/ Atrevis 100 mg/mL GEL, 90 gm pump, Rx, The Medicine Shoppe Ph... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Estriol 5 mg Suppository 36 each box, Rx, The Medicine Shoppe Pharmacy, Port ... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar, Rx, The Medicine Shoppe Pharmacy,... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (50/50)/Progesterone/Testost 1.5/100/0.5 mg Cream 30 gm tube, Rx, The ... | 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 | Progesterone 200 mg Capsules 90 capsules, Rx, The Medicine Shoppe Pharmacy, P... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Estradiol Vag Cream 0.01% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy,... | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 (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 | 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 | 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 | 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 | 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 (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 | 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 | 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 | 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 | 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 | 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/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 | 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 | Paregoric Alternate Elixir 300 mL bottle, Rx, The Medicine Shoppe Pharmacy, P... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medic... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medici... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy,... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL b... | 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 30 mg over 9 hours (3.... | 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 10 mg over 9 hours (1.... | 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 | 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 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... |
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.