Browse Drug Recalls

1,309 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,309 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 1,309 FDA drug recalls in 2014.

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DateProductReasonClassFirm
Mar 3, 2014 Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Ma... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only... Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the P... Class III Novartis Pharmaceuticals Corp.
Mar 3, 2014 Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, O... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine,... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid ... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. ... Penicillin Cross Contamination Class II Terra-Medica Inc.
Feb 26, 2014 Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 cou... Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphe... Class III Pfizer Us Pharmaceutical Group
Feb 26, 2014 All sterile drugs compounded between 2/21/14 and 2/24/14. Lack of Assurance of Sterility: All compounded products. Class II New England Home Therapies, Inc
Feb 20, 2014 Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint F... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 coun... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combin... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Loze... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vi... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 coun... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Loze... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vi... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 coun... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 20, 2014 Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count ... Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class III GlaxoSmithKline Consumer Healthcare; dba-GlaxoS...
Feb 19, 2014 Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarat... Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug. Class III Gilead Sciences, Inc.
Feb 14, 2014 CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals... Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrullin... Class I Medisca Inc
Feb 14, 2014 Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratorie... Presence of Particulate Matter: During a review of retain samples, the firm found a glass particu... Class I Ben Venue Laboratories Inc
Feb 14, 2014 etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 m... Presence of Particulate Matter: Potential for small black particles to be present in individual v... Class II Agila Specialties Private Ltd.
Feb 14, 2014 Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: W... Chemical Contamination: The recalling firm received notice that their supplier is recalling capsu... Class II Legacy Pharmaceutical Packaging
Feb 13, 2014 Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which re... Class II Noven Pharmaceuticals, Inc.
Feb 13, 2014 BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-... Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPiv... Class II Healix Infusion Therapy, Inc.
Feb 13, 2014 Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which re... Class II Noven Pharmaceuticals, Inc.
Feb 12, 2014 Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-6... Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. Class II Teva Pharmaceuticals USA
Feb 12, 2014 Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in P... Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. Class II Teva Pharmaceuticals USA
Feb 11, 2014 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hosp... Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, ... Class II Hospira Inc.
Feb 11, 2014 Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactur... Cross Contamination with Other Products: Product contains Promacta (eltrombopag). Class III Viiv Healthcare Company
Feb 11, 2014 Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Fl... Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag ... Class I Baxter Healthcare Corp.
Feb 11, 2014 QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cy... Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point Class III Teva Pharmaceuticals USA
Feb 10, 2014 Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free... Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the ... Class II Hospira Inc.
Feb 10, 2014 Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx... Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than No... Class III Pinnacle Biologics Inc
Feb 10, 2014 Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured ... Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for... Class II Actavis Elizabeth LLC
Feb 7, 2014 Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephed... Defective Container: An unacceptable level of blister defects have been identified in Loratadine ... Class II Ohm Laboratories, Inc.
Feb 7, 2014 Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use... Subpotent Drug: Drug potency was compromised during shipment. Class III Actavis
Feb 4, 2014 Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, ... Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. Class II Actavis Elizabeth LLC
Feb 4, 2014 Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan ... Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenes... Class III Aaron Industries Inc
Jan 31, 2014 SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-... Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from... Class II American Health Packaging
Jan 31, 2014 ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-... Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from... Class II American Health Packaging
Jan 31, 2014 Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical O... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, 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.