Browse Drug Recalls

1,110 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,110 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 1,110 FDA drug recalls in CA.

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DateProductReasonClassFirm
Mar 25, 2016 CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 ... Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine Class I Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All thyroid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDI... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Peterson Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE CO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All diltiazem Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUN... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Midrin (isometheptene mucate, dichloralphenazone and acetaminophen) Produ... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All citalopram Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All testosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All T4-levothyroxine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE ... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All hydroxyurea Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All retinoic acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All hydrocortisone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE CO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All mirtazapine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All melatonin Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUN... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All quinacrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All minocycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All hydroxyzine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All nifedipine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All lidocaine, meloxicam, diclofenac and baclofen Products, Rx Only, Compound... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All cocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDI... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All fluoxymesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE C... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All betamethasone diproprionate Products, Rx Only, Compounded by RELIABLE DRU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All sulfapyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Jack Newman Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All triamcinolone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All spironolactone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE CO... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 17, 2016 Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distribu... Labeling: Incorrect or Missing Lot and/or Exp. Date Class III Impax Laboratories, Inc.
Mar 17, 2016 Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distribu... Labeling: Incorrect or Missing Lot and/or Exp. Date Class III Impax Laboratories, Inc.
Feb 4, 2016 Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml sy... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Phar... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 10 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pha... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx onl... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol. 20 ml syringe Rx on... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, ... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol.... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml, vol. 40 ml syringe, Rx... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe, Rx on... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe, Rx o... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Baclofen 5000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 2 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharm... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Ph... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 10 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Phar... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx ... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ C... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml, vol. 40 ml syringe, R... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, ... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Har... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 1 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharm... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 1.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Phar... Lack of Assurance of Sterility Class II 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.