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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
Jun 1, 2015 Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 6808... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
May 29, 2015 Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bo... Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... Class II Apotex Inc.
May 29, 2015 Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufacture... Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... Class II Apotex Inc.
May 29, 2015 Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufacture... Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... Class II Apotex Inc.
May 29, 2015 Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured... Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... Class II Apotex Inc.
May 28, 2015 Morphine Sulfate, MORPHINE SULFATE 1000mg / NS 100mL, Qty: 1 50 mL Bag, Rx On... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamin... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Vancomycin, VANCOMYCIN 750mg / NS 100mL AccuFlo, Qty: 7 100 mL Bags, Rx Only.... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Fluorouracil 1400mg / D5W 278mL Qty: 1 278 mL Bag, Rx Only. Compounded by: U... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travaso... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Fluorouracil 1200mg / D5W 274mL, Qty: 1 274 mL Bag, Rx Only. Compounded by: ... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Cefepime HCl, Cefepime 2 gm / NS 100 mL AccuFlo, Qty: 14 100 mL Bags, Rx Only... Lack of Assurance of Sterility: Sterility of product is not assured Class II Lincare, Inc.
May 28, 2015 Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 12 150 mL Bags... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 CefTRIAXone Sodium, Ceftriaxone 1 gram / NS 50 mL, Qty: 10 50 mL Bags, Rx Onl... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intra... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Ganciclovir Sodium, 250MG / NS 100ML, QTY: 6 100 mL Bags, Rx Only. Compounde... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 HYDROmorphone HCl PF, HYDROMORPHONE HCL 1000mg /NS 500mL, Qty: 1 500 mL Bag... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only. ... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL sy... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 1440 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intra... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 mL Bags, Rx Only. ... Lack of Assurance of Sterility: Sterility of product is not assure Class II Lincare, Inc.
May 28, 2015 Fluorouracil 4800mg / D5W 296mL, Qty: 1 296 mL Bag, Rx Only. Compounded by: U... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Vancomycin HCl in Dextrose, VANCOMYCIN 500mg / D5W 100mL AccuFlo, Qty: 12 100... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 6 150 mL Bags,... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 VANCOMYCIN 1.25gm / NS 250mL AccuFlo, Qty: 7 250 mL Bags, Rx Only. Compounded... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Trava... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Vancomycin 750 mg/NS 100 ml accuflo, Packaged in 100 mL Bags, Rx Only. Compo... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intra... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 FLUOROURACIL 1560MG / D5W 281ML, Qty: 1 281 mL Bag, Rx Only. Compounded by: U... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 mL Bags, Rx Onl... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 CIPROFLOXACIN 400MG / D5W 200ML ACCUFLO, Packaged in 3 200 mL Bags, Rx Only. ... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Cl... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Vancomycin HCl / Heparin, Vancomycin 50mcg/ml / HEPARIN 100u/ml, Qty: 8, Rx O... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 2400 mL Bag, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Tra... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 1090 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intra... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3, Rx Onl... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Fluorouracil 3200mg / D5W 264mL, Qty: 1 264 mL Bag, Rx Only. Compounded by: ... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Fentanyl Citrate, FENTANYL 25,000 MCG / 500 ML, Qty: 1 500 mL Bag, Rx Only. ... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Cl... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Vancomycin 1000mg / NS 100mL, Packaged in 100 mL Bags, Rx Only. Compounded b... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 CEFTRIAXONE SODIUM 2000mg / NS 50mL, Qty:4 50 mL Bags, Rx Only. Compounded by... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 817 mL Bags, Qty: 5, Base Formula Dextrose 70%, Trophamine 10%, Intr... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, 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.