Browse Drug Recalls
193 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 193 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 193 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| May 15, 2014 | Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C S... | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... | Class II | Franck's Lab Inc dba Trinity Care Solutions |
| Apr 16, 2014 | Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx ... | Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended... | Class II | Pfizer Us Pharmaceutical Group |
| 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 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 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. |
| Apr 30, 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-coun... | Subpotent Drug: The products were below specification for potency at the expiry stability point. | Class II | King Legacy, a wholly owned subsidiary of Pfizer |
| Apr 30, 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-coun... | Subpotent Drug: The products were below specification for potency at the expiry stability point. | Class II | King Legacy, a wholly owned subsidiary of Pfizer |
| Apr 30, 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count... | Subpotent Drug: The products were below specification for potency at the expiry stability point. | Class II | King Legacy, a wholly owned subsidiary of Pfizer |
| Apr 30, 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-coun... | Subpotent Drug: The products were below specification for potency at the expiry stability point. | Class II | King Legacy, a wholly owned subsidiary of Pfizer |
| Apr 30, 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-coun... | Subpotent Drug: The products were below specification for potency at the expiry stability point. | Class II | King Legacy, a wholly owned subsidiary of Pfizer |
| Apr 30, 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count... | Subpotent Drug: The products were below specification for potency at the expiry stability point. | Class II | King Legacy, a wholly owned subsidiary of Pfizer |
| Apr 30, 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-coun... | Subpotent Drug: The products were below specification for potency at the expiry stability point. | Class II | King Legacy, a wholly owned subsidiary of Pfizer |
| Apr 30, 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count... | Subpotent Drug: The products were below specification for potency at the expiry stability point. | Class II | King Legacy, a wholly owned subsidiary of Pfizer |
| Apr 30, 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-coun... | Subpotent Drug: The products were below specification for potency at the expiry stability point. | Class II | King Legacy, a wholly owned subsidiary of Pfizer |
| Apr 30, 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count... | Subpotent Drug: The products were below specification for potency at the expiry stability point. | Class II | King Legacy, a wholly owned subsidiary of Pfizer |
| Apr 30, 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-coun... | Subpotent Drug: The products were below specification for potency at the expiry stability point. | Class II | King Legacy, a wholly owned subsidiary of Pfizer |
| 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. |
| Jun 6, 2012 | Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL... | Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degrad... | Class II | Meridian Medical Technologies a Pfizer Company |
| Sep 19, 2011 | Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 3... | Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-packa... | Class II | Physicians Total Care, 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.