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.

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DateProductReasonClassFirm
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.