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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
Apr 13, 2015 EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 m... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 ... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 ... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mc... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured b... Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity ... Class II Teva Pharmaceuticals USA
Apr 13, 2015 HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Inj... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose via... Crystallization Class II Hospira Inc.
Apr 13, 2015 Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose via... Crystallization Class II Hospira Inc.
Apr 12, 2015 Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx On... Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil ar... Class I Stroheckers Inc Pharmacy
Apr 10, 2015 ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe... Failed pH specification Class III Oasis Medical, Inc.
Apr 10, 2015 MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-D... Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include on... Class III Medtech Products, Inc.
Apr 7, 2015 Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, M... Subpotent drug Class III Apotex Inc.
Apr 7, 2015 Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 605... Subpotent drug Class III Apotex Inc.
Apr 7, 2015 0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufa... Lack of Sterility Assurance: The product has the potential to leak at the administrative port. Class II Hospira Inc.
Apr 7, 2015 Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) b... Failed Impurities/Degradation Specifications Class II Akorn, Inc.
Apr 7, 2015 Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 6050... Subpotent drug Class III Apotex Inc.
Apr 7, 2015 Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) b... Failed Impurities/Degradation Specifications Class II Akorn, Inc.
Apr 2, 2015 Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 co... Subpotent Drug: The firm received an out of specification result for Assay (potency was below spe... Class II Boehringer Ingelheim Roxane Inc
Mar 31, 2015 C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC... Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as... Class II Cody Laboratories, Inc.
Mar 26, 2015 Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihista... Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Mar 26, 2015 Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, ... Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of ... Class III Actavis Laboratories, FL, Inc.
Mar 25, 2015 PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10... Failed Impurities/Degradation Specifications: A stability lot was out of specification for a know... Class III Qualitest Pharmaceuticals
Mar 25, 2015 GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bot... Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. Class II Heritage Pharmaceuticals, Inc.
Mar 24, 2015 Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, ... Failed Content Uniformity Specifications: The product may not meet finished product release speci... Class III Nomax Inc
Mar 24, 2015 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactu... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 24, 2015 Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Flu... Failed Content Uniformity Specifications: The product may not meet finished product release speci... Class III Nomax Inc
Mar 24, 2015 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxte... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 24, 2015 Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL... Failed Content Uniformity Specifications: The product may not meet finished product release speci... Class III Nomax Inc
Mar 24, 2015 Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by ... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 24, 2015 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Bax... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 23, 2015 Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 23, 2015 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi P... Lack of Assurance of Sterility; increased complaints received for leaks Class II Baxter Healthcare Corp
Mar 23, 2015 Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 23, 2015 Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 23, 2015 Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose... Lack of Assurance of Sterility; increased complaints received for leaks Class II Baxter Healthcare Corp
Mar 18, 2015 CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Mul... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 18, 2015 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Man... Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which ma... Class II Baxter Healthcare Corp.
Mar 18, 2015 Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, pac... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 18, 2015 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx ... Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which ma... Class II Baxter Healthcare Corp.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon We... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fal... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mc... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmac... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 300... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Welln... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL... Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class II Akorn, Inc.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellne... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Well... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL,... Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class II Akorn, Inc.
Mar 17, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL,... Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class II Akorn, 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.