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Browse Drug Recalls

1,301 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,301 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 1,301 FDA drug recalls in IL.

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DateProductReasonClassFirm
Feb 23, 2015 Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5... Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic an... Class II Sagent Pharmaceuticals Inc
Feb 23, 2015 Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only,... Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic an... Class II Sagent Pharmaceuticals Inc
Feb 18, 2015 Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL ... Lack of Assurance of Sterility; due to leaking vials Class II Mylan Institutional LLC
Feb 18, 2015 Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL... Lack of Assurance of Sterility; due to leaking vials Class II Mylan Institutional LLC
Feb 12, 2015 Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane,... Labeling: Illegible label. Writing is rubbing off of labels. Class III Nanophase Technologies Corporation
Feb 11, 2015 DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use... Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may... Class III Mylan Institutional LLC
Jan 28, 2015 Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 2... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodi... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, ... Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed US... Class II Akorn, Inc.
Jan 23, 2015 KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vi... Crystallization Class II Hospira Inc.
Jan 23, 2015 KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Via... Crystallization Class II Hospira Inc.
Jan 23, 2015 Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dos... Subpotent Drug and Failed Impurities/Degradation Specifications Class III Mylan Institutional LLC
Jan 20, 2015 0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Fore... Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in... Class I Hospira Inc.
Jan 13, 2015 fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 ... Subpotent Drug Class I Pharmedium Services, LLC
Jan 13, 2015 fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride,... Subpotent Drug Class I Pharmedium Services, LLC
Dec 23, 2014 Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single pati... Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the n... Class II Hospira Inc.
Dec 23, 2014 Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRA... Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam. Class II Baxter Healthcare Corp.
Dec 22, 2014 0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira... Lack of Assurance of Sterility: The product has the potential for solution to leak at the adminis... Class II Hospira Inc.
Dec 9, 2014 Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size:... Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 ... Class III Akorn, Inc.
Dec 4, 2014 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, ... Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue ... Class I Baxter Healthcare Corp
Dec 3, 2014 Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose F... Lack of Assurance of Sterility; improperly crimped fliptop vials Class II Hospira Inc.
Dec 3, 2014 MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake F... Failed Stability Specifications: Product is subpotent and has out of specification known and unkn... Class I Hospira Inc.
Nov 25, 2014 Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx... Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when st... Class III Hospira Inc.
Nov 25, 2014 Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% De... Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal Class II Baxter Healthcare Corp.
Nov 12, 2014 GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Do... Defective Container: Vials may be missing stoppers. Class II Fresenius Kabi USA, LLC
Nov 10, 2014 Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose con... Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were inc... Class II Baxter Healthcare Corp.
Nov 7, 2014 Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g... Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another ... Class III Hospira Inc.
Oct 30, 2014 Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500... Subpotent Drug: Heparin raw material was found to have low potency Class II Baxter Healthcare Corp.
Oct 24, 2014 Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactur... Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thick... Class II Hospira Inc.
Oct 20, 2014 Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane,... cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lo... Class III Nanophase Technologies Corporation
Oct 16, 2014 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Fr... Presence of particulate matter: A returned customer sample was evaluated and found to have human ... Class I Hospira Inc.
Oct 14, 2014 Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL contai... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, R... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only,... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx O... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospi... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufacture... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx O... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 6, 2014 Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Flipto... Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class II Hospira Inc.
Oct 6, 2014 Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop V... Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class II Hospira 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.