August 5, 2026DrugsFDA
MYLAN PHARMACEUTICALS INC recalls Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: M
Hazard: Presence of precipitate
August 5, 2026DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA,
Hazard: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
August 5, 2026DrugsFDA
MICRO LABS USA INC recalls Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro La
Hazard: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
July 29, 2026DrugsFDA
Supernus Pharmaceuticals, Inc. recalls Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solution
Hazard: Failed Dissolution Specifications
July 29, 2026DrugsFDA
Bionpharma Inc. recalls Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., P
Hazard: Presence of Foreign Tablets/Capsules
July 29, 2026DrugsFDA
Precision Dose Inc. recalls Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dos
Hazard: Failed Impurities/Degradation Specifications
July 29, 2026DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, IND
Hazard: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
July 29, 2026DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, IND
Hazard: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
July 29, 2026DrugsFDA
JB Chemicals and Pharmaceuticals Ltd recalls Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.
Hazard: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
July 29, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, S
Hazard: Presence of Particulate Matter: Hair was found in products
July 29, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, S
Hazard: Presence of Particulate Matter: Hair was found in products
July 29, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose
Hazard: Presence of Particulate Matter: Hair was found in products
July 29, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 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
Hazard: Presence of Particulate Matter: Hair was found in products
July 29, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 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 V
Hazard: Presence of Particulate Matter: Hair was found in product
July 29, 2026DrugsFDA
Rising Pharma Holding, Inc. recalls Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdin
Hazard: Presence of Precipitate: medication was crystallizing and particles floating in the bottle
July 29, 2026DrugsFDA
Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL)
Hazard: Lack of Assurance of Sterility
July 29, 2026DrugsFDA
Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Dis
Hazard: Lack of Assurance of Sterility
July 29, 2026DrugsFDA
Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: Th
Hazard: Lack of Assurance of Sterility
July 29, 2026DrugsFDA
Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distribut
Hazard: Lack of Assurance of Sterility
July 29, 2026DrugsFDA
Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4
Hazard: Lack of Assurance of Sterility
July 29, 2026DrugsFDA
Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL
Hazard: Lack of Assurance of Sterility
July 29, 2026DrugsFDA
Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL),
Hazard: Lack of Assurance of Sterility
July 29, 2026DrugsFDA
Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL O
Hazard: Lack of Assurance of Sterility
July 29, 2026DrugsFDA
Asclemed USA Inc. recalls Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by
Hazard: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
July 29, 2026DrugsFDA
Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laborat
Hazard: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
July 29, 2026DrugsFDA
Major Pharmaceuticals recalls Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Pack
Hazard: Subpotent Drug
July 29, 2026DrugsFDA
Major Pharmaceuticals recalls Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Pack
Hazard: Subpotent Drug
July 29, 2026DrugsFDA
Major Pharmaceuticals recalls Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packag
Hazard: Subpotent Drug
July 29, 2026DrugsFDA
Major Pharmaceuticals recalls Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packag
Hazard: Subpotent Drug
July 29, 2026DrugsFDA
Major Pharmaceuticals recalls Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packag
Hazard: Subpotent Drug