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Browse Drug Recalls

1,198 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,198 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 1,198 FDA drug recalls in 2016.

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DateProductReasonClassFirm
May 2, 2016 Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufa... Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obt... Class III Sandoz, Inc
May 2, 2016 Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufa... Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obt... Class III Sandoz, Inc
Apr 29, 2016 BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifes... Marketed without an approved NDA/ANDA - presence of undeclared sildenafil. Class I Making It a Lifestyle
Apr 29, 2016 3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifesty... Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. Class II Making It a Lifestyle
Apr 29, 2016 BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it... Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. Class I Making It a Lifestyle
Apr 28, 2016 Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distribu... Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found. Class II Pfizer Inc.
Apr 28, 2016 Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administra... Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray can... Class II Lymol Medical
Apr 27, 2016 Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled ... Defective Delivery System; may have a low frequency assembly fault which may result in pens block... Class II Novo Nordisk Inc
Apr 27, 2016 Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Ge... Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL ... Class III Genzyme Corporation / Genzyme Biosurgery
Apr 27, 2016 Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-3... Lack of Assurance of Sterility: Due to potential for leaking bags. Class II Teva North America
Apr 25, 2016 Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Do... Presence of Particulate Matter: Glass particulate found in sterile injectable product Class II Fresenius Kabi USA, LLC
Apr 22, 2016 Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bot... Labeling: Not elsewhere classified - count on the label was incorrect. Class III A-S Medication Solutions LLC.
Apr 22, 2016 CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottl... Failed impurities/degradation specification: An out of specification results has been determined ... Class III Dr. Reddy's Laboratories, Inc.
Apr 20, 2016 Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by P... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compo... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Mon... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, C... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKO... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Br... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only,... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceu... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peopl... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, ... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded b... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHAR... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peopl... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV U... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx O... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, U... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a ... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Mono... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARM... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;,... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PA... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, 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.