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Browse Drug Recalls

295 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 295 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 295 FDA drug recalls in AR.

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DateProductReasonClassFirm
Sep 12, 2015 Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ al... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regi... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For To... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only,... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM In... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophtha... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Inj... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injec... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regiona... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic us... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regio... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Comp... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Inje... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalm... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, R... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Aug 21, 2015 MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug... Subpotent Drug Class II Cantrell Drug Company
Aug 21, 2015 fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe,... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, R... Stability Data Does Not Support Expiry Class II Cantrell Drug Company
Aug 21, 2015 Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syr... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL... Subpotent Drug Class II Cantrell Drug Company
Aug 21, 2015 Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), ... Subpotent Drug Class II Cantrell Drug Company
Aug 21, 2015 MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL... Subpotent Drug Class II Cantrell Drug Company
Aug 21, 2015 fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), ... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL s... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe,... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), ... Stability Data Does Not Support Expiry Class II Cantrell Drug Company
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.

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.