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Browse Drug Recalls

515 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 515 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 515 FDA drug recalls.

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DateProductReasonClassFirm
Jul 24, 2015 ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x... Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution Class I Teva Pharmaceuticals USA
Jul 17, 2015 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Si... Presence of Particulate Matter: Customer complaint for an insect found free floating inside a sin... Class I Baxter Healthcare Corp.
Jul 17, 2015 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags,... Presence of Particulate Matter: Customer complaint for an insect found free floating inside a sin... Class I Baxter Healthcare Corp.
Jul 2, 2015 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxt... Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint ... Class II Baxter Healthcare Corp.
Apr 28, 2015 Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct In... Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone ... Class I Teva Pharmaceuticals USA
Apr 23, 2015 Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL... Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. Class I Hospira Inc.
Apr 23, 2015 Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-... Presence of Particulate Matter Class I Mylan Institutional LLC
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 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 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 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 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 HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose In... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
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 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 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 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 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 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, 2 g*/vial, Lyophilized powder in a Single-Use... Presence of Particulate Matter Class I Mylan Institutional LLC
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 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 11, 2015 LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, M... Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the soluti... Class I Hospira Inc.
Mar 5, 2015 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospi... Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution. Class I Hospira Inc.
Feb 24, 2015 Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syring... Presence of particulate. Class II SCA Pharmaceuticals
Feb 23, 2015 PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan H... Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product. Class II Qualitest Pharmaceuticals
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 21, 2015 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distr... Presence of Particulate Matter: lot is not meeting the specification limit for number of particle... Class II Sun Pharma Global Fze
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.
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 12, 2014 Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American ... Presence of Particulate Matter; preservative may not have dissolved completely or precipitated ou... Class II American Specialty Pharmacy
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
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.
Sep 30, 2014 Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) table... Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates. Class III Gilead Sciences, Inc.
Sep 11, 2014 HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.... Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between ... Class I Hospira Inc.
Sep 4, 2014 Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Fre... Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown,... Class II Hospira Inc.
Aug 8, 2014 CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only,... Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at th... Class I Cubist Pharmaceuticals, Inc.
Aug 7, 2014 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... Presence of Particulate Matter: particulate matter was found during the manufacturing process. Class I Baxter Healthcare Corp.
Aug 4, 2014 ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container ... Presence of Particulate Matter: identification of particulates in a retention sample that have be... Class II Baxter Healthcare Corp
Aug 1, 2014 CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufact... Presence of Particulate Matter: Potential presence of glass particulate matter in the vials. Class I Cubist Pharmaceuticals, Inc.
Jul 30, 2014 Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: S... Presence of Foreign Substance; tablets may contain stainless steel metal particulates Class II Mckesson Packaging Services
Jul 29, 2014 Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Singl... Presence of Particulate Matter: The product was discolored and contained visible particulates (ir... Class I Hospira Inc.
Jul 25, 2014 Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeto... Presence of Foreign Substance; tablets may contain stainless steel metal particulates Class II Sandoz Incorporated

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.