Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 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 2,085 FDA drug recalls in 2013.

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Date	Product	Reason	Class	Firm
May 21, 2013	0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (ND...	Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p...	Class II	Baxter Healthcare Corp.
May 21, 2013	Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count u...	Crystallization; crystallized nimodipine	Class II	Sun Pharmaceutical Industries Inc.
May 21, 2013	Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 20...	Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p...	Class II	Baxter Healthcare Corp.
May 20, 2013	Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, ...	Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles f...	Class II	Hospira, Inc.
May 20, 2013	Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL S...	Presence of Particulate Matter: Found during examination of retention samples.	Class I	Sandoz Incorporated
May 20, 2013	JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle	Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutram...	Class I	Dolphin Intertrade Corporation
May 20, 2013	XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box	Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutram...	Class I	Dolphin Intertrade Corporation
May 17, 2013	Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician S...	Failed Impurities/Degradation Specifications: unspecified degradation product	Class II	Warner Chilcott US LLC
May 16, 2013	West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bott...	Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks ...	Class II	West-Ward Pharmaceutical Corp.
May 16, 2013	West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bott...	Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets containe...	Class II	West-Ward Pharmaceutical Corp.
May 16, 2013	Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, ...	Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.	Class II	Hospira Inc.
May 15, 2013	Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino aci...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialys...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dial...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen...	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.	Class III	Novartis Consumer Health
May 15, 2013	Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorph...	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.	Class III	Novartis Consumer Health
May 15, 2013	Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysat...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution wi...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - di...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysat...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution wi...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysat...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solutio...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution wi...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution ...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 cap...	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing	Class III	Novartis Consumer Health
May 15, 2013	IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amin...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextrometho...	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing	Class III	Novartis Consumer Health
May 15, 2013	HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufa...	Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and C...	Class II	Health & Beyond
May 15, 2013	Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit...	Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an ...	Class III	Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 15, 2013	Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution ...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorph...	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.	Class III	Novartis Consumer Health
May 15, 2013	Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlor...	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.	Class III	Novartis Consumer Health
May 15, 2013	Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution ...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactu...	Failed Impurity/Degradation Specification; "Related Compound C"	Class II	Actavis South Atlantic LLC
May 15, 2013	Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorphen...	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.	Class III	Novartis Consumer Health
May 13, 2013	Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufa...	Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who disc...	Class I	Zydus Pharmaceuticals USA Inc
May 13, 2013	Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as...	Non-Sterility; contract laboratory identified Staphylococcus warneri in the product	Class I	Abrams Royal Pharmacy
May 13, 2013	Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use...	Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpu...	Class III	West-ward Pharmaceutical Corp.
May 10, 2013	Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk ...	Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon rec...	Class I	Apotex Corp.
May 8, 2013	Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML	Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopano...	Class II	Fusion Pharmaceuticals, LLC
May 7, 2013	Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 11...	Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during t...	Class III	Hill Dermaceuticals, Inc.
May 6, 2013	Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89...	Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA anal...	Class I	Chang Kwung Products
May 6, 2013	Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 8...	Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA anal...	Class I	Chang Kwung Products
May 3, 2013	Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Excl...	Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredi...	Class II	Kareway Product Inc
May 2, 2013	Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compoundi...	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co...	Class II	THE COMPOUNDING SHOP, INC.
May 2, 2013	Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding ...	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co...	Class II	THE COMPOUNDING SHOP, INC.
May 2, 2013	B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Sh...	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co...	Class II	THE COMPOUNDING SHOP, INC.
May 2, 2013	Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compound...	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co...	Class II	THE COMPOUNDING SHOP, INC.
May 2, 2013	Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Sho...	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co...	Class II	THE COMPOUNDING SHOP, 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.