Browse Drug Recalls
1,710 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,710 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 1,710 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 9, 2014 | Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle... | Failed Impurities/Degradation Specifications: out of specification results for impurities/degrada... | Class III | Caraco Pharmaceutical Laboratories, Ltd. |
| Apr 4, 2014 | Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laborator... | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the pr... | Class III | Boehringer Ingelheim Roxane Inc |
| Apr 4, 2014 | Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laborato... | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the pr... | Class III | Boehringer Ingelheim Roxane Inc |
| Apr 1, 2014 | Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 F... | Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone... | Class III | Genesis Pharmaceutical, Inc. |
| Apr 1, 2014 | PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Kon... | Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. | Class III | Konsyl Pharmaceuticals Inc |
| Mar 27, 2014 | Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spi... | Defective Delivery System: Potential for dose delivery out of specification due to interation of ... | Class III | Boehringer Ingelheim Roxane Inc |
| Mar 25, 2014 | Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, R... | Labeling; Missing label; ampoules are missing the immediate container label | Class III | Hospira Inc. |
| Mar 20, 2014 | Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Ap... | Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 mont... | Class III | Apotex Inc. |
| Mar 17, 2014 | Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial... | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | Class III | John W Hollis Inc |
| Mar 17, 2014 | Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Ph... | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | Class III | John W Hollis Inc |
| Mar 3, 2014 | Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets ... | Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval. | Class III | McKesson Packaging Services |
| Mar 3, 2014 | Ritalin HCl (methylphenidate HCl) USP, 10 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 | 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. |
| 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 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 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 | 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 | 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 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 | 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 | 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 | 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. |
| Jan 31, 2014 | ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oi... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Jan 29, 2014 | Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E... | Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% ra... | Class III | Fougera Pharmaceuticals Inc. |
| Jan 28, 2014 | Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets ... | Failed Impurity/degradation Specification | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Jan 27, 2014 | Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstit... | Failed Impurities/Degradation Specifications: Product did not meet specification in total impurit... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 27, 2014 | Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstitute... | Failed Impurities/Degradation Specifications: Product did not meet specification in total impurit... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 13, 2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister... | This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate... | Class III | Merck & Co Inc |
| Jan 13, 2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister... | This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate... | Class III | Merck & Co Inc |
| Jan 13, 2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister... | This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate... | Class III | Merck & Co Inc |
| Jan 13, 2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister... | Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which c... | Class III | Merck & Co Inc |
| Jan 2, 2014 | Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.... | Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of spec... | Class III | Pfizer Inc. |
| Dec 16, 2013 | Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) ... | Failed impurities/degradation specifications; out of specification for the known impurity 4-chlor... | Class III | Qualitest Pharmaceuticals |
| Dec 16, 2013 | VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx On... | Failed Stability Testing: This product is below specification for preservative content. | Class III | Bracco Diagnostics 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.