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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
Aug 24, 2015 The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 c... Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... Class I Novacare, LLC
Aug 24, 2015 Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 caps... Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... Class I Novacare, LLC
Aug 24, 2015 Thin and Slim Naturally The Natural Alternative AM Dietary Supplement package... Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... Class I Novacare, LLC
Aug 24, 2015 Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules... Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... Class I Novacare, LLC
Aug 24, 2015 Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged i... Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... Class I Novacare, LLC
Aug 24, 2015 Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in cont... Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... Class I Novacare, LLC
Aug 21, 2015 MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug... Subpotent Drug Class II Cantrell Drug Company
Aug 21, 2015 fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe,... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, R... Stability Data Does Not Support Expiry Class II Cantrell Drug Company
Aug 21, 2015 Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syr... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx o... Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the... Class III Silarx Pharmaceutical, Inc.
Aug 21, 2015 LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL... Subpotent Drug Class II Cantrell Drug Company
Aug 21, 2015 Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), ... Subpotent Drug Class II Cantrell Drug Company
Aug 21, 2015 Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone ... Defective Container: Product missing safety seal around the neck of the bottle. The product labe... Class III Akorn, Inc.
Aug 21, 2015 MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL... Subpotent Drug Class II Cantrell Drug Company
Aug 21, 2015 fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), ... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, pa... Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling pr... Class II Nephron Pharmaceuticals Corp.
Aug 21, 2015 fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL s... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Race... Discoloration Class II Nephron Pharmaceuticals Corp.
Aug 21, 2015 fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (... Discoloration Class II Nephron Pharmaceuticals Corp.
Aug 21, 2015 fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe,... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), ... Stability Data Does Not Support Expiry Class II Cantrell Drug Company
Aug 20, 2015 RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lak... Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known im... Class III Akorn, Inc.
Aug 20, 2015 Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose... Defective Container: There were customer complaints of cracked and leaking glass vials. Class II Hospira Inc.
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 m... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Tot... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in ... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 ... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 1... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosag... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syri... Subpotent drug. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syrin... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharma... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syring... Subpotent drug. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, ... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 m... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syring... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, ... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in s... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syrin... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL i... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 17, 2015 Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupi... Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to... Class I Hartley Medical Center Pharmacy, Incorporated
Aug 17, 2015 Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 1... Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to... Class I Hartley Medical Center Pharmacy, Incorporated

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.