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Browse Drug Recalls

1,733 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,733 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 1,733 FDA drug recalls in 2015.

Clear
DateProductReasonClassFirm
Jun 8, 2015 ESTRIOL Face Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 2-DEOXY-D-GLUCOSE Powder, Rx, compounded by Life Science Pharmacy Inc., Harri... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 TRI-EST Liquids, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 TRI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 HYDROXOCOBALAMIN Injection, Rx, compounded by Life Science Pharmacy Inc., Har... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 5, 2015 Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (... CGMP Deviation: Poor container closure of the bulk storage container Class III Geritrex Corp
Jun 4, 2015 Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured ... Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degra... Class II Fresenius Kabi USA, LLC
Jun 4, 2015 Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor ach... Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of t... Class III Indiana Botanic Gardens, Inc
Jun 4, 2015 Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 ... Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth contro... Class III Actavis Inc
Jun 3, 2015 Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 50... Subpotent Drug; out of specification results for heparin raw material Class II Baxter Healthcare Corp
Jun 3, 2015 Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic ... Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutra... Class I Centro Naturista
Jun 3, 2015 Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic ... Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutra... Class I Centro Naturista
Jun 2, 2015 HCG 1,100 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 Testosterone 20 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 HCG 1,250 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 Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding P... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 60 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 Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 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 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclo... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Ste... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone 12.5 mg, Sterile Pellet, 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 Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Bacl... 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 AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of Ame... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 B-Complex 100 mg/ml Injection, Sterile, Refrigerate, 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 PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, 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 Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, S... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharm... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile,... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The C... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding P... 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 200 mcg/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 Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, Th... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, T... 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 Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT,... 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/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compou... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Co... 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 (6.9/0.575/39.375) Injectable, The Compounding Pharmacy of America, K... 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 Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, 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 Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., K... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Lipovicine Modified II Injectable, 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 MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of A... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Estradiol 8 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 Tri-Mix (37.5 mg/1.5 mg/50 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 Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile... 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-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America,... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-... 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.