Browse Drug Recalls
14,483 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,483 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 14,483 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compo... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Comp... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by ... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Comp... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoje... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Comp... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PA... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syr... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The People... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Phar... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD s... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Co... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHA... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Com... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Co... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compoun... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Com... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 m... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Co... | 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.