Browse Drug Recalls

17,897 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,897 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 17,897 FDA drug recalls.

DateProductReasonClassFirm
Jun 12, 2018 ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 551... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, Inc.
Jun 12, 2018 Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. ... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, Inc.
Jun 12, 2018 HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (U... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextros... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dex... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% De... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chlorid... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL)... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chlorid... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP)... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL sing... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 m... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. ... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, Inc.
Jun 12, 2018 MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 1... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (U... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacai... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chlorid... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodiu... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropiva... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (U... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chlor... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL sing... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 11, 2018 Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II BioDiagnostic International
Jun 8, 2018 Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Sin... Superpotent Drug: High out of specification assay value results for potency. Class II Ingenus Pharmaceuticals Llc
Jun 8, 2018 TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Q... Labeling: Incorrect or Missing Lot and/or Exp Date. Class III Qualgen, LLC
Jun 8, 2018 Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Sing... Superpotent Drug: High out of specification assay value results for potency. Class II Ingenus Pharmaceuticals Llc
Jun 8, 2018 ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualge... Labeling: Incorrect or Missing Lot and/or Exp Date. Class III Qualgen, LLC
Jun 7, 2018 Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 m... Superpotent Drug: Composite assay results obtained during routine stability testing were slightly... Class III Mylan Pharmaceuticals Inc.
Jun 6, 2018 Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, pa... Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility. Class II Pharmalucence, Inc.
Jun 5, 2018 HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in... Superpotent and Subpotent Class II PharMEDium Services, LLC
Jun 4, 2018 Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Si... Presence of Particulate Matter; Potential for particulate matter on the syringe plunger. Class I HOSPIRA INC, LAKE FOREST
May 31, 2018 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray... Presence of foreign substance: glass particles Class II Apotex 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.