FDA & USDA Recalls

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Current View: Drugs • Showing 50 recalls
OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)
RECALLWebsite NoticeOngoing
Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass
Date: 08-03-2026|Location: N/A
Adequan Canine Injection and Adequan i.m Injection for horses
RECALLWebsite NoticeOngoing
Visible glass fiber material in the product
Date: 08-02-2026|Location: N/A
Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL
RECALLWebsite NoticeOngoing
Products were found to contain particulate matter
Date: 07-26-2026|Location: N/A
Cefazolin in Dextrose Injection
RECALLWebsite NoticeOngoing
Particulate matter (cardboard) found in the solution.
Date: 07-23-2026|Location: N/A
Cyclophosphamide for Injection
RECALLWebsite NoticeOngoing
Presence of particulate matter identified as steel
Date: 07-23-2026|Location: N/A
Cetirizine Hydrochloride Tablets USP 5 mg
RECALLWebsite NoticeOngoing
Potential cross contamination with Ranitidine
Date: 07-19-2026|Location: N/A
Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03
RECALLClass IIOngoing
Presence of Particulate Matter: Hair was found in products
Date: 07-16-2026|Location: N/A|Recall No: D-0729-2026
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
RECALLClass IIOngoing
Presence of Particulate Matter: Hair was found in products
Date: 07-16-2026|Location: N/A|Recall No: D-0728-2026
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05
RECALLClass IIOngoing
Presence of Particulate Matter: Hair was found in products
Date: 07-16-2026|Location: N/A|Recall No: D-0727-2026
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01
RECALLClass IIOngoing
Presence of Particulate Matter: Hair was found in products
Date: 07-16-2026|Location: N/A|Recall No: D-0726-2026
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
RECALLClass IIOngoing
Presence of Particulate Matter: Hair was found in product
Date: 07-16-2026|Location: N/A|Recall No: D-0725-2026
Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01.
RECALLClass IIIOngoing
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Date: 07-15-2026|Location: N/A|Recall No: D-0713-2026
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
RECALLClass IIOngoing
Lack of Assurance of Sterility
Date: 07-14-2026|Location: N/A|Recall No: D-0722-2026
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
RECALLClass IIOngoing
Lack of Assurance of Sterility
Date: 07-14-2026|Location: N/A|Recall No: D-0721-2026
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1
RECALLClass IIOngoing
Lack of Assurance of Sterility
Date: 07-14-2026|Location: N/A|Recall No: D-0720-2026
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1
RECALLClass IIOngoing
Lack of Assurance of Sterility
Date: 07-14-2026|Location: N/A|Recall No: D-0719-2026
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
RECALLClass IIOngoing
Lack of Assurance of Sterility
Date: 07-14-2026|Location: N/A|Recall No: D-0718-2026
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
RECALLClass IIOngoing
Lack of Assurance of Sterility
Date: 07-14-2026|Location: N/A|Recall No: D-0717-2026
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
RECALLClass IIOngoing
Lack of Assurance of Sterility
Date: 07-14-2026|Location: N/A|Recall No: D-0716-2026
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1
RECALLClass IIOngoing
Lack of Assurance of Sterility
Date: 07-14-2026|Location: N/A|Recall No: D-0715-2026
Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.
RECALLClass IIOngoing
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Date: 07-13-2026|Location: N/A|Recall No: D-0724-2026
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61
RECALLClass IIOngoing
Subpotent Drug
Date: 07-13-2026|Location: N/A|Recall No: D-0711-2026
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61
RECALLClass IIOngoing
Subpotent Drug
Date: 07-13-2026|Location: N/A|Recall No: D-0710-2026
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61
RECALLClass IIOngoing
Subpotent Drug
Date: 07-13-2026|Location: N/A|Recall No: D-0709-2026
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61
RECALLClass IIOngoing
Subpotent Drug
Date: 07-13-2026|Location: N/A|Recall No: D-0708-2026
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61
RECALLClass IIOngoing
Subpotent Drug
Date: 07-13-2026|Location: N/A|Recall No: D-0707-2026
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61
RECALLClass IIOngoing
Subpotent Drug
Date: 07-13-2026|Location: N/A|Recall No: D-0706-2026
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61
RECALLClass IIOngoing
Subpotent Drug
Date: 07-13-2026|Location: N/A|Recall No: D-0705-2026
Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61
RECALLClass IIOngoing
Subpotent Drug
Date: 07-13-2026|Location: N/A|Recall No: D-0704-2026
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61
RECALLClass IIOngoing
Subpotent Drug
Date: 07-13-2026|Location: N/A|Recall No: D-0703-2026
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61
RECALLClass IIOngoing
Subpotent Drug
Date: 07-13-2026|Location: N/A|Recall No: D-0702-2026
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61
RECALLClass IIOngoing
Subpotent Drug
Date: 07-13-2026|Location: N/A|Recall No: D-0701-2026
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61
RECALLClass IIOngoing
Subpotent Drug
Date: 07-13-2026|Location: N/A|Recall No: D-0700-2026
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31
RECALLClass IIOngoing
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Date: 07-09-2026|Location: N/A|Recall No: D-0690-2026
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
RECALLClass IIOngoing
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Date: 07-08-2026|Location: N/A|Recall No: D-0712-2026
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.
RECALLClass IIOngoing
Lack of Assurance of Sterility
Date: 07-06-2026|Location: N/A|Recall No: D-0689-2026
Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-412-02
RECALLClass IIOngoing
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Date: 06-29-2026|Location: N/A|Recall No: D-0676-2026
Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-411-02
RECALLClass IIOngoing
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Date: 06-29-2026|Location: N/A|Recall No: D-0675-2026
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count 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
RECALLClass IIOngoing
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Date: 06-29-2026|Location: N/A|Recall No: D-0661-2026
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.
RECALLClass IIOngoing
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Date: 06-26-2026|Location: N/A|Recall No: D-0660-2026
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.
RECALLClass IIOngoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Date: 06-25-2026|Location: N/A|Recall No: D-0688-2026
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
RECALLClass IIOngoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Date: 06-25-2026|Location: N/A|Recall No: D-0687-2026
Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.
RECALLClass IIOngoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Date: 06-25-2026|Location: N/A|Recall No: D-0686-2026
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.
RECALLClass IIOngoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Date: 06-25-2026|Location: N/A|Recall No: D-0685-2026
GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.
RECALLClass IIOngoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Date: 06-25-2026|Location: N/A|Recall No: D-0684-2026
FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.
RECALLClass IIOngoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Date: 06-25-2026|Location: N/A|Recall No: D-0683-2026
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
RECALLClass IIOngoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Date: 06-25-2026|Location: N/A|Recall No: D-0682-2026
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
RECALLClass IIOngoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Date: 06-25-2026|Location: N/A|Recall No: D-0681-2026
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.
RECALLClass IIOngoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Date: 06-25-2026|Location: N/A|Recall No: D-0680-2026
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
RECALLClass IIOngoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Date: 06-25-2026|Location: N/A|Recall No: D-0679-2026