Browse Drug Recalls
138 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 138 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 138 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 2, 2015 | Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, pac... | Failed Dissolution Specification | Class III | Pfizer Inc. |
| Sep 24, 2015 | Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed b... | Subpotent Drug | Class II | Pfizer Inc. |
| Apr 23, 2015 | Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-... | Presence of Particulate Matter | Class I | Mylan Institutional LLC |
| Mar 23, 2015 | Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-... | Presence of Particulate Matter | Class I | Mylan Institutional LLC |
| Mar 18, 2015 | Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, pac... | Presence of Particulate Matter | Class I | Mylan Institutional LLC |
| 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 26, 2015 | Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufac... | Failed Impurities/Degradation Specifications | Class III | Pfizer Inc. |
| Dec 3, 2014 | Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61... | Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cra... | Class II | Pfizer Inc. |
| Oct 10, 2014 | TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL an... | Crystallization: Impurities in a raw material used to manufacture the diluent can cause the forma... | Class III | Pfizer Inc. |
| Jul 30, 2014 | Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL... | Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval a... | Class III | Pfizer Inc. |
| Jul 8, 2014 | VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only... | Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect ex... | Class III | Pfizer Inc. |
| Jun 19, 2014 | Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottl... | Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications f... | Class III | Pfizer Inc. |
| Apr 8, 2014 | Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfi... | Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discover... | Class II | Pfizer 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 6, 2014 | Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a... | Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg ca... | Class I | Pfizer Us Pharmaceutical Group |
| 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. |
| Jan 29, 2014 | GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, ... | Defective Container: Tamper evident ring failures discovered on some bottles. | Class II | Pfizer 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. |
| Nov 4, 2013 | Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, R... | Failed Dissolution Specification; 8 hr stability timepoint | Class III | Pfizer Inc. |
| Sep 13, 2013 | Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intrave... | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Ameri... | Class II | AmeriSource Bergen |
| Sep 13, 2013 | Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intrav... | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Ameri... | Class II | AmeriSource Bergen |
| Sep 4, 2013 | Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, ... | Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d... | Class II | Pfizer Us Pharmaceutical Group |
| Jun 4, 2013 | Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD... | Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflect... | Class II | Pharmacia & Upjohn LLC |
| May 31, 2013 | Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, pac... | Failed Dissolution Specification | Class III | Pfizer Inc |
| May 31, 2013 | Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.... | Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogen... | Class III | Pfizer Inc. |
| May 31, 2013 | Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.... | Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxy... | Class III | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count ... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened.. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count ... | Chemical contamination: emission of strong odor after package was opened.. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-coun... | Chemical contamination: emission of strong odor after package was opened | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count ... | Chemical contamination: emission of strong odor after package was opened.. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Nov 26, 2012 | TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packa... | Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the di... | Class III | Pfizer 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.