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
Jul 18, 2012 Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & C... Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary... Class III Fougera Pharmaceuticals Inc.
Jul 18, 2012 Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Ace... Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free ... Class II LNK International, Inc.
Jul 16, 2012 X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 1... Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sil... Class I Coral Rock Man, Inc.
Jul 16, 2012 Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792... Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sil... Class I Coral Rock Man, Inc.
Jul 13, 2012 CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g... Microbial Contamination of Non Sterile Product; mold Class II Island Kinetics dba Covalence
Jul 12, 2012 Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.
Jul 12, 2012 Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 m... Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packagi... Class III Axcentria Pharmaceuticals LLC
Jul 12, 2012 Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.
Jul 12, 2012 Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.
Jul 11, 2012 Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 ... Subpotent; some patches may not contain fentanyl gel Class II Actavis
Jul 9, 2012 Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, ... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, R... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, ... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 9, 2012 Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, ... cGMP Deviations; does not meet in process specification requirements Class II Lloyd Inc. of Iowa
Jul 6, 2012 HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg... Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month roo... Class III Vintage Pharmaceuticals LLC DBA Qualitest Pharm...
Jul 6, 2012 NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufact... Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90... Class II Glenmark Generics Inc., USA
Jul 6, 2012 HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bot... Impurities/Degradation Products: High Out of Specification results for a known impurity resulted ... Class III Vintage Pharmaceuticals LLC DBA Qualitest Pharm...
Jul 5, 2012 Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, M... Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline... Class II Ben Venue Laboratories Inc
Jul 2, 2012 Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count b... Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexi... Class III ASTRA ZENECA Lp
Jul 2, 2012 Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) ... Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin AP... Class III Hospira Inc.
Jun 29, 2012 Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceu... Failed USP Content Uniformity Requirements: OOS result reported on retained samples. Class II Mylan LLC.
Jun 29, 2012 Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottl... Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dis... Class II Prometheus Laboratories Inc.
Jun 28, 2012 Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceutic... Impurities/Degradation Products: Out of specification results for Related Compound during routine... Class III Mylan Pharmaceuticals Inc.
Jun 28, 2012 Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 dose... Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Fact... Class III Health Plus Incorporated
Jun 27, 2012 Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplas... The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, a... Class II Hospira Inc.
Jun 27, 2012 Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplas... The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, a... Class II Hospira Inc.
Jun 27, 2012 Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antin... The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, a... Class II Hospira Inc.
Jun 27, 2012 Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplasti... The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, a... Class II Hospira Inc.
Jun 26, 2012 Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg... Presence of Particulate Matter Class I Ben Venue Laboratories Inc
Jun 21, 2012 Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, ... CGMP Deviations: Shipment of product not approved for release. Class III Hospira, Inc.
Jun 21, 2012 OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 6... CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation Class II Oklahoma Respiratory Care Inc
Jun 20, 2012 Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (3... Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the ... Class II Medtech Products, Inc.
Jun 18, 2012 Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only... Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "oi... Class III Stat Rx USA
Jun 14, 2012 Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.... Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufact... Class II Dukal Corp.
Jun 14, 2012 Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl o... Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated ... Class II Kimberly-Clark Corporation
Jun 14, 2012 ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (eff... Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufact... Class II Dukal Corp.
Jun 14, 2012 Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Lit... Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated ... Class II Kimberly-Clark Corporation
Jun 7, 2012 Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only.... Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di... Class III Fougera Pharmaceuticals, Inc.
Jun 6, 2012 Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL... Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degrad... Class II Meridian Medical Technologies a Pfizer Company
Jun 5, 2012 Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physi... Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly... Class II Bristol-myers Squibb Company
Jun 5, 2012 Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, M... Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C ... Class III JHP Pharmaceuticals, LLC
Jun 5, 2012 Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physi... Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly... Class II Bristol-myers Squibb Company

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.