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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
Feb 11, 2015 DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use... Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may... Class III Mylan Institutional LLC
Feb 10, 2015 Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles,... Failed Dissolution Specifications Class II Actavis Elizabeth LLC
Feb 6, 2015 Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg... Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-mo... Class II Tarmac Products, Inc.
Jan 28, 2015 Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, ... Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed US... Class II Akorn, Inc.
Jan 28, 2015 PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodi... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 2... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 26, 2015 Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Ph... Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from... Class II AnazaoHealth Corporation
Jan 25, 2015 AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highw... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making... Class I Detox Transforms
Jan 25, 2015 iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein an... Class I Detox Transforms
Jan 25, 2015 EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein an... Class I Detox Transforms
Jan 25, 2015 BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, m... Class I Detox Transforms
Jan 25, 2015 iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highw... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, m... Class I Detox Transforms
Jan 23, 2015 Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dos... Subpotent Drug and Failed Impurities/Degradation Specifications Class III Mylan Institutional LLC
Jan 23, 2015 KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Via... Crystallization Class II Hospira Inc.
Jan 23, 2015 KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vi... Crystallization Class II Hospira Inc.
Jan 21, 2015 Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Ma... Failed Dissolution Specifications: 6 month time point. Class II Sun Pharma Global Fze
Jan 21, 2015 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distr... Presence of Particulate Matter: lot is not meeting the specification limit for number of particle... Class II Sun Pharma Global Fze
Jan 20, 2015 0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Fore... Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in... Class I Hospira Inc.
Jan 20, 2015 Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx ... Non-Sterility: Product tested positive for bacterial contamination. Class I Pacifico National, Inc. dba AmEx Pharmacy
Jan 20, 2015 Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, Am... Non-Sterility: Product tested positive for bacterial contamination. Class I Pacifico National, Inc. dba AmEx Pharmacy
Jan 13, 2015 fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride,... Subpotent Drug Class I Pharmedium Services, LLC
Jan 13, 2015 fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 ... Subpotent Drug Class I Pharmedium Services, LLC
Jan 12, 2015 Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3... Defective Delivery System: One lot exceeded the mechanical peel specification Class II Noven Pharmaceuticals, Inc.
Jan 8, 2015 5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-08... Subpotent Drug Class III Freedom Pharmaceuticals Inc
Jan 6, 2015 Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags,... Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or... Class I Wallcur Incorporated
Jan 6, 2015 Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and D... Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet caps... Class II American Health Packaging
Jan 2, 2015 Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syrin... Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" a... Class II SCA Pharmaceuticals

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.