Browse Drug Recalls

534 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 534 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 534 FDA drug recalls in 2012.

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DateProductReasonClassFirm
Sep 4, 2012 Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber ... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, ... Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength. Class III Apace KY LLC
Sep 4, 2012 Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Su... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Re... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Aug 31, 2012 0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hosp... Presence of Particulate Matter; product may contain fibrous material Class I Hospira Inc.
Aug 29, 2012 Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusio... Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample... Class II Hospira Inc.
Aug 29, 2012 BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactu... Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine v... Class I Bristol-myers Squibb Company
Aug 28, 2012 Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 m... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial Class II Hospira Inc.
Aug 28, 2012 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.
Aug 28, 2012 Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metere... Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indica... Class II Dispensing Solutions, Inc
Aug 28, 2012 I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, O... Lack of Assurance of Sterility: The product is being recalled because the product label does not ... Class II James G. Cole, Inc.
Aug 27, 2012 Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information ... Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets beca... Class I Samantha Lynn, Inc
Aug 23, 2012 Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUS... Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warn... Class III Ferring Pharmaceuticals Inc
Aug 23, 2012 Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Dist... Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules." Class III Stat Rx USA
Aug 23, 2012 Mojo Nights for Her, 1 capsule, UPC 7 18122 12133 5, Distributed By: Mojo Hea... Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredien... Class I Evol Nutrition
Aug 23, 2012 Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Laud... Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredien... Class I Evol Nutrition
Aug 21, 2012 Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count u... Crystallization: Presence of crystals of Nimodipine within the capsule solution. Class II Caraco Pharmaceutical Laboratories Ltd.
Aug 21, 2012 Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Ma... Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who dis... Class II Ranbaxy Inc.
Aug 17, 2012 Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by... Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide... Class III Axcentria Pharmaceuticals LLC
Aug 15, 2012 HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject pr... Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfille... Class I Hospira Inc.
Aug 15, 2012 Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For ... Subpotent; fluocinolone acetonide. Class III Galderma Laboratories, L.P.
Aug 14, 2012 Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate... Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... Class III Actavis Mid Atlantic LLC
Aug 14, 2012 Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials ... Presence of Particulate Matter; potential for charcoal particulates Class III Bracco Diagnostic Inc
Aug 14, 2012 Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phen... Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... Class III Actavis Mid Atlantic LLC
Aug 7, 2012 Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactu... Cross Contamination w/Other Products: During stability testing chromatographic review revealed ex... Class II Mylan Pharmaceuticals Inc.
Aug 3, 2012 Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patien... Presence of Particulate Matter: A single visible particulate was observed and confirmed in a samp... Class II Hospira Inc.
Aug 1, 2012 Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. R... Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... Class II Dr. Reddy's Laboratories, Inc.
Aug 1, 2012 Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. ... Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... Class II Dr. Reddy's Laboratories, Inc.
Aug 1, 2012 Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. R... Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... Class II Dr. Reddy's Laboratories, Inc.
Jul 30, 2012 Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solutio... Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels... Class III Mallinckrodt Inc
Jul 30, 2012 Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20... Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials ... Class I Genentech Inc
Jul 27, 2012 Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured fo... Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign... Class II Mylan Pharmaceuticals Inc.
Jul 27, 2012 Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rin... Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphing... Class II Capco Custom Packaging Inc
Jul 27, 2012 Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 f... Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkh... Class III Natural Essentials Inc
Jul 26, 2012 Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200... Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specificat... Class II GlaxoSmithKline Inc
Jul 25, 2012 Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, R... Subpotent; 9-month stability interval Class II Lloyd Inc. of Iowa
Jul 25, 2012 Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, R... Subpotent; 9-month stability interval Class II Lloyd Inc. of Iowa
Jul 25, 2012 Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, R... Subpotent; 9-month stability interval Class II Lloyd Inc. of Iowa
Jul 25, 2012 Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, R... Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly... Class III American Health Packaging
Jul 25, 2012 Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, R... Subpotent; 9-month stability interval Class II Lloyd Inc. of Iowa
Jul 24, 2012 OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single... Presence of Particulate Matter: The firm initiated the recall due to visible presence of particul... Class II Cadence Pharmaceuticals
Jul 23, 2012 Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters pe... Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratori... Class II American Health Packaging
Jul 23, 2012 Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #:... Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride b... Class II Custom Medical Specialties, Inc.
Jul 23, 2012 CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 m... Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride b... Class II Custom Medical Specialties, Inc.
Jul 23, 2012 CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chlor... Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride b... Class II Custom Medical Specialties, Inc.
Jul 23, 2012 Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , M... Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (A... Class III Stat Rx USA
Jul 19, 2012 Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottl... Defective Container: A number of Synthroid bottles have a localized thin wall defect on the botto... Class II Abbott Laboratories
Jul 19, 2012 Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottl... Defective Container: A number of Synthroid bottles have a localized thin wall defect on the botto... Class II Abbott Laboratories
Jul 19, 2012 Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bott... Defective Container: A number of Synthroid bottles have a localized thin wall defect on the botto... Class II Abbott Laboratories

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.