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Browse Drug Recalls

989 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 989 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 989 FDA drug recalls in TN.

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DateProductReasonClassFirm
Dec 12, 2016 Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing ... cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. Class III VIRTUS PHARMACEUTICALS OPCO II L
Dec 12, 2016 Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Min... cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. Class III VIRTUS PHARMACEUTICALS OPCO II L
Dec 12, 2016 Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Di... cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. Class III VIRTUS PHARMACEUTICALS OPCO II L
Sep 19, 2016 Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Net... Superpotent and Subpotent drugs Class II Wells Pharmacy Network, LLC
Sep 19, 2016 Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class III Wells Pharmacy Network, LLC
Sep 19, 2016 Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class III Wells Pharmacy Network, LLC
Sep 19, 2016 Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Ne... Superpotent and Subpotent drugs Class II Wells Pharmacy Network, LLC
Sep 19, 2016 Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class III Wells Pharmacy Network, LLC
Sep 19, 2016 Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class III Wells Pharmacy Network, LLC
Sep 19, 2016 Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Ne... Superpotent and Subpotent drugs Class II Wells Pharmacy Network, LLC
Sep 2, 2016 Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx ... Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. Class I VIRTUS PHARMACEUTICALS OPCO II L
Sep 2, 2016 Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only,... Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. Class I VIRTUS PHARMACEUTICALS OPCO II L
Sep 2, 2016 Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottl... Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. Class I VIRTUS PHARMACEUTICALS OPCO II L
May 10, 2016 Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (1... Labeling; Product Contains Undeclared API (Oxybenzone) Class II Bayer Health Care LLC
Apr 4, 2016 BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. ... Microbial Contamination of Non-Sterile Products: Failed S.aureus test. Class II Keystone Laboratories Inc
Feb 8, 2016 Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ... Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus au... Class II Keystone Laboratories Inc
Oct 13, 2015 Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine H... Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as a... Class III Rx PAK
Sep 23, 2015 Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Inje... Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being com... Class II Diabetes Corporation of America dba DCA Pharmacy
Jun 2, 2015 Estradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Kn... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone 62.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Kn... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharma... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerat... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dos... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone 60 mg, Sterile Pellet, The Compounding Pharmacy of America, Knox... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 MEGA-BURN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Comp... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvil... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compound... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 PGE 40 (Alprostadil) 40 mcg/ml Injection, ml, Multi-Dose Vial, Sterile, Keep ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrath... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Pr... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable, The Compounding Pharmacy... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Vancomycin 25 mg/ml Ophthalmic Solution, Single Dose, Sterile, Keep Frozen, T... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 MIC-PLUS Carnitine Injectable, Multi-Dose Vial, Sterile, Room Temperature, Th... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharma... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Fentanyl 4,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Pr... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (20/2.5/20) Injectable, Sterile, Keep Frozen, The Compounding Pharma... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 1,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compound... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 64 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free,... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Lipotropic B-12 II* + Lidocaine Injection, Multi-Dose Vial, Sterile, Room Tem... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 1,000 IU/ml + MIC B-12 Injection, Multi-Dose Vial, Sterile, Refrigerate, ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix ST2 (30 mg/3 mg/100 mcg) Injectable, The Compounding Pharmacy of Amer... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Com... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone Cypionate 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Tem... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (17.7 mg/1 mg/10 mcg) Injectable, Sterile, Keep Frozen, The Compoundi... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone Cypionate 40 mg/ml Injectable, 5 Sesame, The Compounding Pharmac... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable, The Compounding Pharmacy... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Steri... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone 70 mg Pellet, Sterile, The Compounding Pharmacy of America, Knox... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Progesterone 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature,... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (17 mg/0.5 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compoundin... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America

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.