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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.

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DateProductReasonClassFirm
Jul 10, 2015 Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Pac... cGMP Deviations Class II PD-Rx Pharmaceuticals, Inc.
Jul 9, 2015 Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 5... cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... Class II Mutual Pharmaceutical Company, Inc.
Jul 9, 2015 Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 5... cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... Class II Mutual Pharmaceutical Company, Inc.
Jul 9, 2015 Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only... cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... Class II Mutual Pharmaceutical Company, Inc.
Jul 7, 2015 Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only... Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24... Class II Kremers Urban Pharmaceuticals, Inc.
Jul 7, 2015 Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only... Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity ... Class II Kremers Urban Pharmaceuticals, Inc.
Jul 6, 2015 Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Join... Subpotent Drug: menthol and methyl salicylate below specification Class III BioComp Pharma, Inc.
Jul 2, 2015 Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distribute... Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutr... Class I XTREME Z DISTRIBUTORS INC
Jul 2, 2015 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxt... Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint ... Class II Baxter Healthcare Corp.
Jul 2, 2015 CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged... Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops. Class III Bestco, Inc.
Jul 2, 2015 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufact... Lack of assurance of sterility: Potential channel leaks near the threaded vial port. Class II Hospira Inc.
Jun 30, 2015 Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-9... Failed Dissolution Specifications Class III GlaxoSmithkline Consmer Healthcare
Jun 30, 2015 Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceu... Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were ob... Class II Mylan Pharmaceuticals Inc
Jun 30, 2015 KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Via... Crystallization; identified as calcium salt of Ketorolac Class II Hospira Inc.
Jun 30, 2015 KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vi... Crystallization; identified as calcium salt of Ketorolac Class II Hospira Inc.
Jun 29, 2015 HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3... Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable Class III Qualitest Pharmaceuticals
Jun 26, 2015 SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compound... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shop... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Com... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compoun... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe,... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Com... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Sho... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Comp... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compo... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Sho... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shopp... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactu... Defective Container: Lids on unit dose cups are not fully qualified. Class III VistaPharm, Inc.
Jun 26, 2015 Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Car... Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell. Class II Ranbaxy Inc.
Jun 26, 2015 SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Sho... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compoun... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Com... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Sho... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apo... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3... Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. Class III American Health Packaging
Jun 24, 2015 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Failed Impurities/Degradation Specifications: out of specification for unknown impurity Class II Teva Pharmaceuticals USA
Jun 23, 2015 CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS R... Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications. Class III Abrams Royal Pharmacy II, LLC
Jun 23, 2015 Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured... Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. Class III Actavis Laboratories, FL, Inc.

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.