Browse Drug Recalls
2,002 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,002 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 2,002 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 4, 2013 | SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodiu... | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... | Class II | CareFusion 213, LLC |
| Mar 4, 2013 | Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1... | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... | Class II | CareFusion 213, LLC |
| Mar 2, 2013 | Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa ... | Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because... | Class III | Physicians Total Care, Inc. |
| Feb 27, 2013 | Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 5... | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ... | Class III | Mutual Pharmaceutical Company, Inc. |
| Feb 27, 2013 | FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102... | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ... | Class III | Mutual Pharmaceutical Company, Inc. |
| Feb 27, 2013 | Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mu... | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ... | Class III | Mutual Pharmaceutical Company, Inc. |
| Feb 27, 2013 | 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, ... | Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injec... | Class II | Baxter Healthcare Corp. |
| Feb 19, 2013 | Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, No... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... | Class III | Novartis Consumer Health |
| Feb 19, 2013 | Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifun... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... | Class III | Novartis Consumer Health |
| Feb 19, 2013 | Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) T... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... | Class III | Novartis Consumer Health |
| Feb 19, 2013 | Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX onl... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... | Class III | Novartis Consumer Health |
| Feb 19, 2013 | Target Up & Up, athlete's foot cream, full prescription strength, terbinafine... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... | Class III | Novartis Consumer Health |
| Feb 4, 2013 | buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carto... | Failed Stability Specifications; out of specification results at the 9 month stability time point... | Class III | American Health Packaging |
| Feb 1, 2013 | CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, R... | Labeling: Missing label | Class III | Fresenius Kabi USA LLC (FK USA) |
| Feb 1, 2013 | TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescripti... | Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Fre... | Class III | Ferring Pharmaceuticals Inc |
| Jan 28, 2013 | Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp.... | Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled wit... | Class III | Stat Rx USA |
| Jan 23, 2013 | Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manuf... | Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect ... | Class III | Mission Pharmacal Co |
| Dec 28, 2012 | Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, M... | Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for ... | Class I | Advance Pharmaceutical Inc |
| Dec 21, 2012 | 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 m... | Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeli... | Class II | Lee Pharmaceuticals, Inc |
| Dec 10, 2012 | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity... | Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded ... | Class III | Upsher Smith Laboratories, Inc. |
| Dec 7, 2012 | Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifen... | Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from t... | Class III | Bayer Healthcare, LLC |
| Dec 4, 2012 | Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per b... | Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contain... | Class II | Abbott Laboratories |
| Nov 30, 2012 | Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, M... | Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Regist... | Class III | West-ward Pharmaceutical Corp. |
| Nov 19, 2012 | EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump ... | Defective Container: Pump head detaching from the canister unit upon removal of the overcap. | Class III | Ascend Therapeutics Inc |
| Nov 8, 2012 | Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor ... | Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the wa... | Class II | Procter & Gamble Co |
| Nov 8, 2012 | Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Steri... | Crystallization: Product is being recalled due to visible particulates identified during a retain... | Class I | Hospira Inc. |
| Oct 23, 2012 | ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxida... | Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stabl... | Class III | Estee Lauder Inc |
| Oct 15, 2012 | AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v)... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g)... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 m... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 ... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid... | Class III | Valeant Pharmaceuticals |
| Sep 28, 2012 | Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%)... | CGMP Deviations: The products were manufactured with raw material which contain unknown particles... | Class III | ITW Dymon |
| Sep 27, 2012 | CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-co... | Short Fill: some bottles contained less than 120-count per labeled claim. | Class III | Genentech, Inc. |
| Sep 21, 2012 | Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | American Enterprises LLC dba Sterling Gelatin |
| 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 |
| 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 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 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 | 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 | 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 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 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. |
| 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 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 | 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 | 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 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 |
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.