Drugs
Drug Recalls
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. See Definitions of Market Withdrawals and Class I, II, and III recalls. All recalls (Class I, II, and III) can be found in the FDA Enforcement Report.
In July 2011, FDA began a pilot program to notify people of drug recalls before they are classified. These unclassified recalls will be published in the Enforcement Report every Wednesday, and will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
If you have a medicine that has been recalled, talk to your health care professional about the best course of action. Stores generally have a return and refund policy when a company has announced a recall of its products.
NOTE: The recalls on the list are generally Class I., which means there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
2012 Recalls
- September 10, 2012 Qualitest Recalls One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg
- September 04, 2012 Sun Pharmaceutical Industries, Inc. Recalls One Lot of Nimodipine Capsules due to Crystallization of the Fill Material
- August 15, 2012 Hospira Recalls One Lot of Hydromorphone Hydrochloride Injection 2 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject
- August 14, 2012 Hospira Recalls Three Lots Of Propofol Due To Glass Vial Defect
- July 25, 2012 DUKAL Corporation recalls selected lots of benzalkonium chloride swabs and antiseptic wipes
- July 13, 2012 Hospira Recalls Certain Lots of Injectable Carboplatin, Cytarabine, Paclitaxel and Methotrexate
- July 03, 2012 Bedford Laboratories Recalls Leucovorin Calcium Injection
- June 28, 2012
Bedford Laboratories Issues Voluntary Hospital/User-Level Recall Of Vecuronium Bromide For Injection Preservative Free, Lot 2067134, Because Of Health Risk - June 05, 2012
Sandoz US Announces Precautionary Recall Of Oral Contraceptive Introvale®, Following Report Of Packaging Flaw - May 25, 2012 Franck’s Pharmacy: Compounded Prescription Recall
- May 12, 2012 Hospira Recalls One Lot Of Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume
- May 02, 2012 Franck's Compounding Lab Recalls Triamcinolone acetonide P.F. 80mg/ml
- April 24, 2012 American Regent Recalls Epinephrine Injection, USP, 1:1000, 1mL Ampules Lot #1395 Due to Discoloration and Small Visible Particles
- April 19, 2012 XROCK INDUSTRIES, LLC Recalls X-ROCK, a Product Marketed as a Dietary Supplement To Support Male Sexual Performance, Due to Unlisted, Potentially Hazardous Ingredient
- April 17, 2012 Hospira Recalls One Lot of Morphine Sulfate Injection, USP 4 MG/ML, (C-II) 1 ML Fill in 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume
- March 31, 2012 Franck's Lab Recalls One Lot of triamcinolone acetonide P.F. 80mg/ml
- April 02, 2012 American Regent Recalls Cyanocobalamin Injection, USP, 100 mcg/mL, 1ml Vial Lot #s 1662, 1679, 1683
- March 09, 2012 Recall of Brilliant Blue G
- February 16, 2012
Bedford Laboratories™ Issues Nationwide Voluntary Recall of Cytarabine for Injection, USP, 1 Gram per Vial - February 24, 2012
Regeneca, Inc. Issues a Voluntary Nationwide Recall of All Lots of Single Capsule RegenErect Because of Potential Health Risks - February 24, 2012 Glenmark Generics Inc. Recalls Seven Lots of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (Generic) Due to Possibility of Out of Sequence Tablets
- February 22, 2012
American Regent Initiates Nationwide Voluntary Recall Of Phenylephrine HCl Injection, USP, 1% 5 mL Vial, Lot# 0693 Due To Visible Particles - February 17, 2012 McNeil Consumer Healthcare Announces Voluntary Nationwide Recall of Infants’ TYLENOL Oral Suspension, 1 oz. Grape Due to Dosing System Complaints
- February 16, 2012 Bedford Laboratories Issues Nationwide Voluntary Recall of Cytarabine for Injection, USP, 1 Gram per Vial
- February 10, 2012
Regeneca, Inc. Issues A Voluntary Nationwide Recall Of A Specific Lot Of RegenArouse Because Of Potential Health Risks - February 09, 2012
Wholistic Herbs, Inc. Recalls "Koff & Kold" and "Kold Sore" Because Of Possible Health Risk - February 06, 2012 North American Rescue, LLC Announces A Follow-Up to the Recall of Crickit Convenience Kits Related to Nationwide Recall of Triad Povidone Iodine Prep Pads
- February 02, 2012
Bedford Laboratories Issues A Voluntary Nationwide Patient Level Recall Of Acetylcysteine Solution, USP, LOT 1877093 - January 31, 2012 Pfizer Recalls Lo/Ovral-28 and Norgestrel/Ethinyl Estradiol Tablets Due to Possibility of Inexact Tablet Counts or Out of Sequence Tablets
- January 27, 2012 One Lot of Aveeno Baby Calming Comfort Lotion Recalled
- January 27, 2012 Cephalon, Inc. recalls Treanda® (bendamustine HCL) for Injection 25mg/Vial Due to Particulate Matter
- January 19, 2012
Perfect Image Solutions, LLC Issues Voluntary Recall of Unapproved Product Due to Potential Health Risk - January 10, 2012 Bedford Laboratories Issues Guidance On 2011 Voluntary Recall Of Polymyxin B For Injection USP And Vecuronium Bromide For Injection Related To Glass Particles
- January 08, 2012 Novartis Consumer Health Inc. Recalls Certain Over-The-Counter Products Due to Potential Presence Of Foreign Tablets Or Chipped Or Broken Tablets Or Gelcaps
2011 Recalls
- December 21, 2011
McNeil Recall of Motrin IB Tablets and Caplets - December 02, 2011 Eagle Pharmaceuticals, Inc. Recalls 4 Lots of Argatroban Injection 50 mg/50 mL (1 mg/mL) Due to a Potential for Visible Particulates
- October 19, 2011 Insight Pharmaceuticals Recalls "Nostrilla Nasal Decongestant" Due To Bacterial Contamination
- October 03, 2011 Superior Metabolic Technologies Inc Recalls Uprizing 2.0 Because the Product Contains Superdrol, Which is a Synthetic Steroid, Making it an Unapproved New Drug
- September 15, 2011
Qualitest Pharmaceuticals Issues a Nationwide Voluntary Recall of Oral Contraceptives - August 24, 2011 H and P Industries, Inc. Recalls All Lots of Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel
- August 02, 2011
American Regent, Inc. Initiates Voluntary Recall of Seventeen Lots of Vasopressin Injection, USP, Multiple Dose Vials Due to Sub-Potency - July 18, 2011 American Regent Initiates Voluntary Nationwide Recall of Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package Due to Particulates
- June 28, 2011
McNeil Consumer Healthcare Announces Voluntary Recall Of One Product Lot Of TYLENOL ® Extra Strength Caplets 225 Count Distributed In The U.S. - June 24, 2011 Qualitest Pharmaceuticals Recalls Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets, USP 50mg/325mg/40mg and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg
- June 24, 2011 Endo Pharmaceuticals Recalls Two Lots of Endocet (Oxycodone/Acetaminophen, USP) Tablets, 10 MG / 325 MG
- June 22, 2011
Nature Relief is Conducting a Voluntary Recall of Nature Relief Instant Wart and Mole Remover - June 17, 2011
Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls One Lot of RISPERDAL® Tablets and One Lot of Risperidone Tablets - June 15, 2011 American Regent Recalls Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial Due to Particulates
- June 06, 2011 American Regent Recalls Methyldopate HCL Injection, USP 5 mL Single Dose Vial Due to Glass Particulates
- June 01, 2011 Aidapak Services, LLC Recalls ALL Repackaged Pharmaceuticals by Aidapak Services, LLC Due to Potential Cross Contamination with Beta Lactam Products
- May 19, 2011
American Regent Initiates Nationwide Voluntary Recall of Sterile Water for Injection, USP 50 mL Single Dose Vial Due to Particulate Matter - May 05, 2011 American Regent Recalls Caffeine and Sodium Benzoate Injection, USP 250 mg/mL, 2 mL Single Dose Vial
- May 02, 2011 Bristol-Myers Squibb Recalls Coumadin (Warfarin Sodium) Crystalline 5 mg Tablets, Lot Number 9H49374A
- April 26, 2011 American Regent Initiates Voluntary Nationwide Recall of Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial
- April 14, 2011
Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX® - March 29, 2011
CDC And ADPH Investigate Outbreak At Alabama Hospitals; Products Recalled - March 26, 2011 Greenstone Recalls Citalopram and Finasteride Due to Possible Mislabeling
- March 25, 2011
APP Pharmaceuticals Issues A Nationwide Voluntary Recall Of Irinotecan Hydrochloride Injection - March 16, 2011
American Regent Initiates Voluntary Nationwide Recall of Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials - March 15, 2011 H and P Industries, Inc. Recall of All Lots of Povidine Iodine Prep Pads
- March 15, 2011 American Regent Recalls Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials
- March 05, 2011
OTC DRUG Nationwide Recall--Important information for patients about IV PREP Antiseptic Wipes - February 18, 2011
Upsher-Smith Laboratories Announces Expansion of Voluntary Nationwide Recall. Affected Products Include Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven® and Oxybutynin - February 16, 2011 Upsher-Smith Laboratories Recalls Jantoven® Warfarin Sodium Tablets, USP, 3mg, Due To Mislabeled Bottles
- February 05, 2011 Qualitest Pharmaceuticals Recalls Hydrocodone Bitartrate and Acetaminophen Tablets and Phenobarbital Tablets
- February 04, 2011
Watson Announces Important Action Related to Nationwide Recall of Triad Alcohol Prep Products Included in Products - February 03, 2011 American Regent Recalls Potassium Phosphates Injection, USP 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium 5 mL Single Dose Vial, Lot# 0048
- January 26, 2011
Pfizer Inc. And Progenics Alert Physicians And Patients To Information Related To Triad Group Alcohol Prep Products Included In U.S. RELISTOR Kit Packaging - January 24, 2011
Important information for ARIXTRA® Starter Kit patients regarding Triad Group’s alcohol prep products - January 14, 2011
McNeil Consumer Healthcare Initiates Voluntary Recall Of Certain Over-The-Counter (OTC) Products - January 13, 2011
Genentech Informs Customers Of Important Information About Triad Groups - January 10, 2011
Important Information for Extavia® (interferon beta 1-b) Patients Regarding Triad Group's Alcohol Prep Products - January 20, 2011
Important Information for Betaseron® (interferon beta 1-b) Consumers Regarding Triad Group’s Alcohol Prep Products - January 06, 2011
Teva Pharmaceuticals, U.S.A issues a voluntary nationwide recall of Metronidazole Tablets USP, 250mg Due to Low Weight Tablets - January 05, 2011
Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination - October 03, 2011
Superior Metabolic Technologies Inc Recalls Uprizing 2.0 Because the Product Contains Superdrol, Which is a Synthetic Steroid, Making it an Unapproved New Drug
2010 Recalls
- December 30, 2010
The Ritedose Corporation Announces the Voluntary Nationwide Recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL Due to Mislabeled Unit Dose Vials - December 30, 2010
Cumberland Pharmaceuticals Announces Voluntary Recall of Acetadote® Vials - December 23, 2010
American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50mL Single Dose Vials Due to Particulate Matter - December 22, 2010
Pfizer To Recall One Lot Of Lipitor In The U.S. - December 20, 2010
American Regent Initiates Voluntary Recall of Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL, 30 mL Multiple Dose Vial
Contact FDA
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