Drug Safety Alerts

Consumer-oriented pharmaceutical information

Drug Safety Alerts

The Food and Drug Administration (FDA) routinely publishes a variety of alerts on its MedWatch system related to safety issues with pharma products.

The agency receives complaints and other safety-related information from health care providers, manufacturers, and consumers on Medwatch, as well as notifications of safety issues from manufacturers.

When the FDA deems it to be appropriate based on the severity of the issue, the volume of complaints or other factors, it will issue a warning or safety alert to health care providers and the public, which is often accompanied by a recall notice issued by the manufacturer to remove affected products from the market.

Warnings and safety alerts can include product issues, ancillary issues that can be a safety hazard, such as labeling, recalls, and any other information related to a negative effect on the safe use of a product.

Pharma Recalls

FDA Drug Safety Alerts

DateAlertMore information
10/14/2026Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate MatterSafety Communication
10/14/2026Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator RecallSafety Communication
10/14/2026Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion SetsSafety Communication
10/13/2026Convenience Kit Recall: Medline Removes Convenience Kits Affected by BD ChloraPrep Applicator RecallSafety Communication
10/09/2026Par Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate MatterSafety Communication
10/06/2026Nova Biomedical® Announces Global Medical Device Correction for StatStrip® Glucose Hospital MeterSafety Communication
10/05/2026IV Tubing Set Correction: ICU Medical Updates Use Instructions for IV Tubing SetsSafety Communication
10/02/2026Breathing Circuit Recall: Draeger Removes VentStar Resus Neo HosesSafety Communication
10/01/2026Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin LevelsSafety Communication
09/21/2026Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride InjectionSafety Communication
09/21/2026Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate MatterSafety Communication
09/13/2026Centric Compounding Issues Nationwide Recall of Glutathione, Myer’s Cocktail, and Tri-Immune Boost Due to Elevated Endotoxin LevelsSafety Communication
09/03/2026B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate MatterSafety Communication
08/26/2026Baxter Issues Voluntary Nationwide Recall for Two Lots of 0.9% Sodium Chloride Injection Due to Potential Presence of Particulate MatterSafety Communication
08/25/2026Baxter Issues Voluntary Nationwide Recall for One Lot of 70% Dextrose Injection Due to Potential Presence of Particulate MatterSafety Communication
08/25/2026Baxter Issues Voluntary Nationwide Recall for One Lot of Anticoagulant Sodium Citrate Solution Due to Potential Presence of Particulate MatterSafety Communication
08/24/2026Vitruvias Therapeutics, Inc Issues Nationwide Recall of One Lot of Thyroid Tablets, USP 30 mg Due to Potential Super PotencySafety Communication
08/20/2026Optimal Balance Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin LevelsSafety Communication
08/19/2026B. Braun Medical Inc. Issues Voluntary North American Recall of Excel® Lactated Ringers Injection, 1000mL Due to the Presence of Particulate MatterSafety Communication
08/11/2026Fresenius Kabi Issues Nationwide Recall of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL Vials Due to Presence of Glass ParticlesSafety Communication
08/05/2026Fresenius Kabi Issues Voluntary Nationwide Recall of One Lot of Morphine Sulfate Injection, USP in a Simplist® Prefilled Syringe Due to Labeling Mix-upSafety Communication
08/05/2026Victory Medical Center Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin LevelsSafety Communication
08/04/2026Liebel-Flarsheim Company, LLC Issues Recall of OPTIRAY Imaging Bulk Package - 350, 500mL, Vial, Nationwide and Mexico Due to Presence of Particulate MatterSafety Communication
08/03/2026American Regent, Inc. Animal Health Issues Nationwide Recall of Two Lots of Adequan® Canine and Two Lots of Adequan® I.M. Due to Visible Glass Fiber Material in the ProductSafety Communication
07/27/2026American Regent, Inc. Issues Voluntary Nationwide Recall of One Lot of Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Due to the Presence of Visible Particulate MatterSafety Communication
07/24/2026Baxter Issues Voluntary Nationwide Recall of Cefazolin in Dextrose Injection, USP, 2G / 100ml(20mg /ml) Single-Dose Infusion Bag in 100ml Due to Particulate Matter Found in SolutionSafety Communication
07/24/2026Sunny Pharmtech, Inc. Issues Voluntary Nationwide Recall of Cyclophosphamide for Injection, USP to the User Level Due to the Presence of Particulate MatterSafety Communication
07/20/2026Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Cross Contamination with RanitidineSafety Communication
06/12/2026Beekeeper’s Naturals Issues Voluntary Nationwide Recall of Beekeeper’s Naturals Saline Nasal Spray Sold Through Amazon Due to Microbial ContaminationSafety Communication
06/10/2026FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney InjurySafety Communication
06/08/2026BD Issues Nationwide Recall for Specific Lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL Applicators Due to Microbial ContaminationSafety Communication
06/04/2026Haleon Issues Voluntary Nationwide Recall of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct.Safety Communication
05/13/2026Sun Pharmaceutical Industries, Inc. (Sun Pharma) Initiates Voluntary U.S. Nationwide Recall of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Due To Potential Presence of Glass ParticlesSafety Communication
05/12/2026Pharmacal Issues Nationwide Recall of MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream Due to Microbial ContaminationSafety Communication
04/28/2026B. Braun Medical, Inc. Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection, 1L, E7500 Due to the Presence of Particulate Matter in SolutionSafety Communication
04/08/2026Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial ContaminationSafety Communication
04/01/2026Aphreseller (Buy-herbal.com) Issues Voluntary Nationwide Recall of Kian Pee Wan Capsules Due the Presence of Undeclared Dexamethasone and CyproheptadineSafety Communication
03/24/2026Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Magnesium Sulfate in Water for Injection, USP 4 g/100mL (NDC 70121-1720-3) Due to a Product Mix-up with Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mLSafety Communication
03/20/2026Cardinal Health Issues Voluntary Nationwide Recall of Webcol™ Large Alcohol Prep PadSafety Communication
01/09/2026Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared MeloxicamSafety Communication
01/09/2026Modern Warrior Recalls “Modern Warrior Ready” Dietary Supplement Due to Undeclared 1,4-DMAA and Aniracetam, as Well as Tianeptine, Which has Not Been Approved for Supplement Use by the FDA.Safety Communication
12/26/2025Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet FoodsSafety Communication
12/22/2025Handelnine Global Limited d/b/a as Navafresh Issues Nationwide Recall of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo), Due to Elevated Lead LevelsSafety Communication
12/16/2025StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and TadalafilSafety Communication
12/16/2025MediNatura New Mexico, Inc. Expands Voluntary Nationwide Recall of ReBoost Nasal Spray and to include ClearLife Allergy Nasal Spray Due to Microbial ContaminationSafety Communication
12/10/2025MediNatura New Mexico, Inc. Issues Voluntary Nationwide Recall of ReBoost Nasal Spray Due to Microbial ContaminationSafety Communication
11/07/2025Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve SamplesSafety Communication
11/03/2025Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride InjectionSafety Communication
09/15/2025BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion SetsSafety Communication
08/29/2025Green Lumber Holding, LLC Issues Consumer Alert on Counterfeit Products Following FDA FindingsSafety Communication
08/28/2025DermaRite Industries Expands Voluntary Nationwide Recall Due to Potential Burkholderia cepacia ContaminationSafety Communication
08/27/2025Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to MislabelingSafety Communication
08/19/2025B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate MatterSafety Communication
08/09/2025DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia ContaminationSafety Communication
08/01/2025FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use: Drug Safety CommunicationSafety Communication
07/14/2025Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within ExpirySafety Communication
07/01/2025Extended-Release Stimulants for ADHD: FDA Drug Safety Communication - FDA Requires Expanded Labeling about Weight Loss Risk in Patients Younger than 6 YearsSafety Communication
06/27/2025Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product MispackagingSafety Communication
06/23/2025Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication - FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea PatchSafety Communication
06/06/2025Church & Dwight Co., Inc. Issues Voluntary Nationwide Recall of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs Due to Microbial ContaminationSafety Communication
06/04/2025Amneal Pharmaceutical LLC Issues a Nationwide Recall of Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Only, Due to Microbial ContaminationSafety Communication
05/23/2025Cetirizine or Levocetirizine: Drug Safety Communication - FDA Warns About Risk of Severe Itching After Discontinuation of Long-Term Use of Allergy MedicinesSafety Communication
05/22/2025UMARY- USA.COM Issues Voluntary Nationwide Recall of UNAVY ÁCIDO HIALURÓNICO Caplets and UMOVY ÁCIDO HIALURÓNICO Caplets Due to the Presence of Undeclared Drug Ingredients Dexamethasone, Diclofenac and OmeprazoleSafety Communication
05/06/2025EnShiShiXiangNiShangMaoYouXianGongSi Issues Voluntary Nationwide Recall of ENDURANCE BOOST WITH HORNY GOAT WEED Capsules Due To Presence of Undeclared Propoxyphenylsildenafil and SildenafilSafety Communication
04/18/2025Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the Potential Presence of Particulate MatterSafety Communication
03/13/2025Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion BagSafety Communication
03/11/2025Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals - Due to Increased Reports of Allergic/Hypersensitivity ReactionsSafety Communication
03/03/2025One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and TadalafilSafety Communication
03/03/2025Power Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+ Power Assist Device Due to Risk for Motor to Be Unresponsive to the UserSafety Communication
02/26/2025Natural Dior LLC Issues Voluntary Nationwide Recall of Vitafer-L Gold Liquid Due to Presence of Undeclared TadalafilSafety Communication
02/25/2025Ascent Consumer Products Inc. Issues Voluntary Nationwide Recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Due to Microbial ContaminationSafety Communication
02/25/2025Central Admixture Pharmacy Services (CAPS) Issues Nationwide Recall of Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags Due to Visible Black Particulate Matter in a Single-Sealed VialSafety Communication
02/20/2025One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and TadalafilSafety Communication
02/18/2025BD Announces Voluntary Worldwide Recall for One Lot of ChloraPrep™ Clear 1 mL Applicators Due to Fungal ContaminationSafety Communication
02/14/2025ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to MislabelingSafety Communication
01/31/2025Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery SystemSafety Communication
01/24/2025Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate MatterSafety Communication
01/22/2025Copaxone, Glatopa (glatiramer acetate): Drug Safety Communication - FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called AnaphylaxisSafety Communication
01/07/2025FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety CommunicationSafety Communication
1/16/2025FDA warns health care professionals not to use epinephrine nasal solutions from BPI Labs and Endo USASafety Communication
11/1/2024FDA warns patients and health care professionals not to use compounded drugs from Fullerton WellnessSafety Communication
10/30/2024Do not purchase or use Skin-Cap Aerosol Spray Products because they may be harmful to your healthSafety Communication
10/2/2024FDA clarifies policies for compounders as national GLP-1 supply begins to stabilizeSafety Communication
9/26/2024FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concernsSafety Communication
9/18/2024FDA warns consumers not to use SnoreStop Nasal Spray by Green Pharmaceuticals due to potential contaminationSafety Communication
9/5/2024FDA warns consumers not to purchase or use Umary and Amazy products as they may be harmful to your healthSafety Communication
8/6/2024FDA warns consumers to not purchase or use unapproved inhalant products marketed for alertness and energy boostingSafety Communication
7/30/2024FDA warns against purchasing or using chemical peel skin products without professional supervisionSafety Communication
5/16/2024FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injectionSafety Communication
4/29/2024FDA alerts health care professionals of pregnancy problems associated with thiopurinesSafety Communication
4/16/2024Counterfeit Version of Botox Found in Multiple StatesSafety Communication
2/23/2024FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)Safety Communication
1/31/2024FDA warns consumers of contaminated copycat eye dropsSafety Communication
1/17/2024FDA announces shelf-life extension for naloxone nasal spraySafety Communication
12/27/2023FDA requires updates to labeling for promethazine hydrochloride injection productsSafety Communication
11/21/2023FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risksSafety Communication
11/3/2023FDA warns consumers of hidden drug ingredients in Dr. Ergin’s SugarMD Advanced Glucose SupportSafety Communication
10/27/2023FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infectionSafety Communication
9/18/2023FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsulesSafety Communication
8/22/2023FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contaminationSafety Communication
8/1/2023FDA warns consumers that Tydemy, a prescription oral contraceptive, may have reduced effectivenessSafety Communication
5/22/2023G-Supress DX Pediatric Cough Drops may have incorrect drug in packagingSafety Communication
5/1/2023FDA warns consumers to not purchase or use Nose Slap and Soul Slap products marketed for alertness and energy boostingSafety Communication
2/9/2023Infants at Risk for Aluminum Toxicity with Unapproved Potassium Phosphates Drug ProductSafety Communication
2/2/2023FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contaminationSafety Communication