Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesCytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Increased rate of out-of-specification endotoxin results.
NHTSATesla, Inc. - Wheel Stud May Separate
Tesla, Inc. - Wheel Stud May Separate
Wheel stud separation can cause a loss of vehicle control, increasing the risk of a crash.
NHTSAToyota Motor Engineering & Manufacturing - Improperly Welded Seat Brackets
Toyota Motor Engineering & Manufacturing - Improperly Welded Seat Brackets
Improperly welded seat brackets can prevent the seat from adequately restraining an occupant during a crash, increasing the risk of injury.
FDA DrugsRemedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Subpotent Drug
FDA DrugsEPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
Lack of Assurance of Sterility
FDA DrugsFluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
FDA DrugsMGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047.
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
FDA DrugsCinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
FDA DrugsDiscount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 44256, Made in China, NDC: 83698-102-30, UPC: 093351037085.
Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 44256, Made in China, NDC: 83698-102-30, UPC: 093351037085.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
FDA Drugscaring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407.
caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
FDA Drugsexchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC 83698-580-30, UPC: 614299398870.
exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC 83698-580-30, UPC: 614299398870.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
FDA DrugsAlbuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
Labelling: Illegible label
FDA DevicesCytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Increased rate of out-of-specification endotoxin results.
FDA DrugsLidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)
Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)
Lack of Assurance of Sterility
FDA DevicesReact Health PHOENIX 5L Oxygen Concentrator
React Health PHOENIX 5L Oxygen Concentrator
Devices which did not meet internal quality specifications were inadvertently distributed.
FDA FoodBooey's Dragon's Breath sauce, 15.2oz ringneck glass bottle. UPC on bottle: 7 01936 29222 3. There are 12 bottles per case. Manufactured Exclusively for BOOEYS GOURMET 3924 N. Cannon St. Spokane, WA 99205. Label declares: INGREDIENTS: Contains Soy and Wheat. *** Soy Sauce (Water, Soybeans, Wheat, Salt ***Squid Sauce (Anchovy Extract) ***Sesame Oil***.
Booey's Dragon's Breath sauce, 15.2oz ringneck glass bottle. UPC on bottle: 7 01936 29222 3. There are 12 bottles per case. Manufactured Exclusively for BOOEYS GOURMET 3924 N. Cannon St. Spokane, WA 99205. Label declares: INGREDIENTS: Contains Soy and Wheat. *** Soy Sauce (Water, Soybeans, Wheat, Salt ***Squid Sauce (Anchovy Extract) ***Sesame Oil***.
Ingredients statement declares Anchovy and Sasame, but Contains statement does not declare Fish (Anchovy) and Sesame.
FDA FoodRaw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00001 8 100% Pure Honey Bee Well Honey 909 W. Main Street Pickens, SC 29671
Raw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00001 8 100% Pure Honey Bee Well Honey 909 W. Main Street Pickens, SC 29671
High sugar content. The firm was notified by the FDA that sample results were positive for a high C4 sugar content.
Germany BVLCrab Blue Swimming Cut U/10 Casabor
Crab Blue Swimming Cut U/10 Casabor
Rückstände und Kontaminanten
FDA DevicesArjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.
FDA DevicesOmnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.
FDA DevicesCytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Increased rate of out-of-specification endotoxin results.
FDA DrugsDesmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
FDA DrugsFluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Germany BVLGourmet Celebi Pistaziencreme 200 Gramm
Gourmet Celebi Pistaziencreme 200 Gramm
Krankheitserreger