Browse Drug Recalls
1,720 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,720 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 1,720 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 24, 2015 | Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Ma... | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Class III | Cipla Limited |
| Apr 20, 2015 | IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02,... | Subpotent Drug: Low out-of-specification potency result of the drug product. | Class III | Akorn, Inc. |
| Apr 18, 2015 | Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100... | Failed Impurities/Degradation Specifications | Class III | Valeant Pharmaceuticals North America LLC |
| Apr 18, 2015 | Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle,... | Failed Impurities/Degradation Specifications | Class III | Valeant Pharmaceuticals North America LLC |
| Apr 15, 2015 | Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 bli... | Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported f... | Class III | Sandoz, Inc |
| Apr 14, 2015 | Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis... | Subpotent Drug: Flurandrenolide is subpotent. | Class III | Actavis Laboratories |
| Apr 10, 2015 | ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe... | Failed pH specification | Class III | Oasis Medical, Inc. |
| Apr 10, 2015 | MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-D... | Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include on... | Class III | Medtech Products, Inc. |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, M... | Subpotent drug | Class III | Apotex Inc. |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 605... | Subpotent drug | Class III | Apotex Inc. |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 6050... | Subpotent drug | Class III | Apotex Inc. |
| Mar 26, 2015 | Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihista... | Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly ... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Mar 26, 2015 | Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, ... | Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of ... | Class III | Actavis Laboratories, FL, Inc. |
| Mar 25, 2015 | PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10... | Failed Impurities/Degradation Specifications: A stability lot was out of specification for a know... | Class III | Qualitest Pharmaceuticals |
| Mar 24, 2015 | Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, ... | Failed Content Uniformity Specifications: The product may not meet finished product release speci... | Class III | Nomax Inc |
| Mar 24, 2015 | Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Flu... | Failed Content Uniformity Specifications: The product may not meet finished product release speci... | Class III | Nomax Inc |
| Mar 24, 2015 | Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL... | Failed Content Uniformity Specifications: The product may not meet finished product release speci... | Class III | Nomax Inc |
| Mar 11, 2015 | Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outd... | Failed Impurities/Degradation Specifications: out of specification results for a related compound... | Class III | Mylan Pharmaceuticals Inc. |
| Mar 10, 2015 | AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen... | Failed Impurities/Degradation Specification; out of specification results for carbon dioxide | Class III | Matheson, Inc. |
| Feb 27, 2015 | Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Ma... | Subpotent Drug | Class III | AVKARE Inc. |
| Feb 27, 2015 | Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Man... | Subpotent Drug | Class III | AVKARE Inc. |
| Feb 26, 2015 | Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufac... | Failed Impurities/Degradation Specifications | Class III | Pfizer Inc. |
| Feb 26, 2015 | Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manuf... | Failed Impurities/Degradation Specifications | Class III | Pfizer Inc. |
| Feb 16, 2015 | Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5... | Failed Impurities/Degradation Specifications; 12 month stability testing. | Class III | West-Ward Pharmaceutical Corporation |
| Feb 12, 2015 | Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, ... | CGMP Deviations: Product excipient was not re-tested at the appropriate date. | Class III | Apotex Inc. |
| Feb 12, 2015 | Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane,... | Labeling: Illegible label. Writing is rubbing off of labels. | Class III | Nanophase Technologies Corporation |
| Feb 11, 2015 | DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use... | Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may... | Class III | Mylan Institutional LLC |
| Jan 23, 2015 | Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dos... | Subpotent Drug and Failed Impurities/Degradation Specifications | Class III | Mylan Institutional LLC |
| Jan 8, 2015 | 5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-08... | Subpotent Drug | Class III | Freedom Pharmaceuticals Inc |
| Dec 26, 2014 | Deferoxamine various strengths in normal saline | Lack of sterility assurance. | Class III | Walgreens Infusion Services |
| Dec 22, 2014 | ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL,... | Failed Impurities/Degradation Specifications: High out of specification results for the known imp... | Class III | Qualitest Pharmaceuticals |
| Dec 19, 2014 | 3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tub... | Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number a... | Class III | 3M Company/3m Espe Dental Products |
| Dec 9, 2014 | sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids... | Failed pH specification: Product pH test value of 5.72 failed to meet its product specification o... | Class III | J. Strickland and Co |
| Dec 9, 2014 | Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size:... | Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 ... | Class III | Akorn, Inc. |
| Dec 5, 2014 | Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sand... | Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an i... | Class III | Sandoz Incorporated |
| Dec 5, 2014 | BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactur... | Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or ill... | Class III | Eisai Inc |
| Dec 4, 2014 | Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (1... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povid... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the C... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: M... | Failed Impurities/Degradation Specifications: Product failed a known impurity specification. | Class III | Micro Labs Usa, Inc ... |
| Dec 4, 2014 | Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline H... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-c... | Failed Impurities/Degradation Specifications: Product failed a known impurity specification. | Class III | Micro Labs Usa, Inc ... |
| Dec 4, 2014 | Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: M... | Failed Impurities/Degradation Specifications: Product failed a known impurity specification. | Class III | Micro Labs Usa, Inc ... |
| Nov 25, 2014 | Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx... | Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when st... | Class III | Hospira Inc. |
| Nov 10, 2014 | Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-releas... | Defective container: A customer complaint revealed the presence of a defective seal on the top of... | Class III | Reckitt Benckiser LLC |
| Nov 7, 2014 | Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g... | Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another ... | Class III | Hospira Inc. |
| Oct 24, 2014 | Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, Car... | Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to h... | Class III | CareFusion 213, LLC |
| Oct 21, 2014 | Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufact... | Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was err... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Oct 20, 2014 | Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane,... | cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lo... | Class III | Nanophase Technologies Corporation |
| Oct 16, 2014 | Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... | Class III | Apotex 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.