Voluntary RecallMedications
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie co
AbbVie Inc.
Failed Stability Specifications
Source: FDA Drug Enforcement (openFDA API)
Medication Recalls
50 recalls— updated every few hours from the FDA's drug enforcement database.
About Medication Recalls
Medication recalls are issued when a prescription or over-the-counter drug is found to be defective, contaminated, or otherwise unsafe. The FDA's Center for Drug Evaluation and Research (CDER) oversees drug recalls in the United States and maintains the enforcement action database that powers this page.
Common causes of drug recalls include microbial or chemical contamination during manufacturing, incorrect potency (meaning a dose contains more or less of the active ingredient than labeled), labeling errors that could lead to medication errors, the presence of foreign particles or sub-potent ingredients, and products that fail sterility testing. In some cases, recalls occur because a facility failed to meet Good Manufacturing Practice (GMP) standards, even if no specific product defect has been identified yet.
Drug recalls are classified the same way as food recalls. A Class I recall means there is a reasonable probability that using the product will cause or lead to serious adverse health consequences or death — for example, a blood pressure medication with no active ingredient, or an injectable drug contaminated with bacteria. A Class II recall covers products that may cause temporary, reversible health effects. A Class III recall involves products that are unlikely to cause harm but violate FDA regulations.
If you take a recalled medication, do not stop taking a prescription without speaking to your doctor or pharmacist first — abruptly discontinuing some medications can be dangerous. Bring the recalled product to your pharmacy; they can check lot numbers and arrange a replacement. Never flush medication down the toilet unless the recall notice specifically instructs you to. Use the FDA's drug take-back program or an approved disposal method.
Important: Always consult your doctor or pharmacist before stopping or switching any prescription medication, even if it has been recalled. Your health provider can advise on the safest course of action.
Voluntary RecallMedications
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, I
AVEVA Drug Delivery Systems, Inc.
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
NoticeMedications
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 36
IntegraDose Compounding Services LLC
Subpotent Drug
NoticeMedications
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, In
ANI Pharmaceuticals, Inc.
Defective Container; packets were found to be either empty or partially full.
NoticeMedications
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Haleon US Holdings LLC
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
NoticeMedications
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna,
UCB Biosciences Inc.
Lack of Assurance of Sterility
Voluntary RecallMedications
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals,
Sagent Pharmaceuticals
Failed Impurities/Degradation Specifications
Voluntary RecallMedications
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Hea
Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Voluntary RecallMedications
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American He
Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
NoticeMedications
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 m
Safecor Health, LLC
Presence of a Foreign Substance; black particles observed in liquid
NoticeMedications
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:
Safecor Health, LLC
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
NoticeMedications
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad,
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
NoticeMedications
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03,
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
NoticeMedications
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad,
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
NoticeMedications
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
NoticeMedications
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
⚠ Active RecallMedications
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0
B BRAUN MEDICAL INC
Presence of Particulate Matter.
NoticeMedications
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical,
Oasis Medical, Inc.
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Voluntary RecallMedications
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Inco
Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Voluntary RecallMedications
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, In
Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
NoticeMedications
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Lab
Ascend Laboratories, LLC
Failed Dissolution Specifications
NoticeMedications
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, M
Lupin Pharmaceuticals Inc.
Presence of particulate matter: a white thread-like structure in the cartridge
⚠ Active RecallMedications
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Phar
Wisconsin Pharmacal Company
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
NoticeMedications
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Voluntary RecallMedications
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136,
Lannett Company Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
NoticeMedications
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea
Thea Pharma, Inc.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
NoticeMedications
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc
Thea Pharma, Inc.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
NoticeMedications
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories
JB Chemicals and Pharmaceuticals Ltd
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
NoticeMedications
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl
CareFusion 213, LLC
Lack of assurance of Sterility: potential product contamination
NoticeMedications
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL
CareFusion 213, LLC
Lack of assurance of Sterility: potential product contamination
NoticeMedications
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas
Alcon Research LLC
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
NoticeMedications
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Marto
Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
NoticeMedications
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort W
Alcon Research LLC
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
NoticeMedications
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LL
Acella Pharmaceuticals, LLC
Chemical contamination; presence of lead and lithium above specification
NoticeMedications
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Ma
SCOPE HEALTH
Lack of Assurance of Sterility
NoticeMedications
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Harrow Eye LLC
Lack of Assurance of Sterility
Voluntary RecallMedications
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent
American Regent, Inc.
Labeling: Missing Label
Voluntary RecallMedications
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Roman
Premier Dental Products Co
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Voluntary RecallMedications
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, A
Unichem Pharmaceuticals USA Inc.
Subpotent drug
NoticeMedications
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Pac
The Harvard Drug Group LLC
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
NoticeMedications
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Ca
Apotex Corp.
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
NoticeMedications
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceu
Hikma Pharmaceuticals USA INC
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Voluntary RecallMedications
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by
Water-Jel Technologies, LLC
Failed PH Specifications
NoticeMedications
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs
Teva Pharmaceuticals USA, Inc
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
NoticeMedications
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2
Fresenius Medical Care Holdings, Inc.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
NoticeMedications
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,
Fresenius Medical Care Holdings, Inc.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
NoticeMedications
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC:
B BRAUN MEDICAL INC
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
NoticeMedications
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC:
B BRAUN MEDICAL INC
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
NoticeMedications
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra M
Huons Co., Ltd.
Lack of Assurance of Sterility
NoticeMedications
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured
Huons Co., Ltd.
Lack of Assurance of Sterility