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Browse Drug Recalls

54 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 54 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 54 FDA drug recalls.

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DateProductReasonClassFirm
May 28, 2015 Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 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 TPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Fluorouracil 4600mg / D5W 292 mL, Qty: 1 292 mL Bag, Rx Only. Compounded by:... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 VANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 mL Syringes, Rx Only. Co... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 CEFEPIME 1gm / NS 50mL AccuFlo, Packaged in 50 mL Bags, Rx Only. Compounded b... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Fluorouracil 5760mg / D5W 265mL Qty: 1 265 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 Ceftriaxone Sodium, Ceftriaxone 2gm / NS 50mL, Qty: 12 50 mL Bags, Rx Only. ... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 mL Bags, Rx Only.... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 HYDROmorphone HCl PF, Hydromorphone 1000 mg / NS 500 mL, Qty: 1 500 mL Bag, R... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: Unit... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syrin... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 VANC 50MCG/ML-HEP 100U/ML in 2ML, Packed in 2 mL Units, Rx Only. Compounded ... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 1750 mL Bags, Qty: 5, 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, Vancomycin 1500mg / D5W 265mL, Qty: 2 265 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, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intr... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 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, 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.
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 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 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 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 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 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 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 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 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, 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 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 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 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 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 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, 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.

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.