FDA Enforcement · Jul 29, 2026
Drug recall: Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Recalls & Safety · page 2
Recalls and safety alerts from the FDA, newest first.
FDA Enforcement · Jul 29, 2026
Drug recall: Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
FDA Enforcement · Jul 29, 2026
Drug recall: Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL)
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 65219 cartons
FDA Enforcement · Jul 29, 2026
Drug recall: Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL
Presence of Particulate Matter: Hair was found in products — Fresenius Kabi USA, LLC · Class II · Ongoing · 93,250 vials
FDA Enforcement · Jul 29, 2026
Drug recall: Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL)
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 97201 cartons
FDA Enforcement · Jul 29, 2026
Drug recall: Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
FDA Enforcement · Jul 29, 2026
Drug recall: Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial
Presence of Particulate Matter: Hair was found in products — Fresenius Kabi USA, LLC · Class II · Ongoing · 181,225 vials
FDA Enforcement · Jul 29, 2026
Drug recall: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN…
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 499,673 cartons
FDA Enforcement · Jul 29, 2026
Drug recall: Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan — Asclemed USA Inc. · Class III · Ongoing · 18 kits
FDA Enforcement · Jul 29, 2026
Drug recall: Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications — Ascend Laboratories, LLC · Class II · Ongoing · 6,192 bottles
FDA Enforcement · Jul 29, 2026
Drug recall: Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
FDA Enforcement · Jul 29, 2026
Drug recall: Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL
Due to an out-of-specification result for an unidentified impurity detected during routine stability testing. — Precision Dose Inc. · Not Yet Classified · Ongoing · N/A
FDA Enforcement · Jul 29, 2026
Drug recall: Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
FDA Enforcement · Jul 29, 2026
Drug recall: Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol…
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 1,278,457 cartons
FDA Enforcement · Jul 29, 2026
Drug recall: Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL
Presence of Particulate Matter: Hair was found in products — Fresenius Kabi USA, LLC · Class II · Ongoing · 37,250 vials
FDA Enforcement · Jul 29, 2026
Drug recall: Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial
Presence of Particulate Matter: Hair was found in product — Fresenius Kabi USA, LLC · Class II · Ongoing · 59,425 vials
FDA Enforcement · Jul 29, 2026
Drug recall: Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
FDA Enforcement · Jul 29, 2026
Drug recall: Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
FDA Enforcement · Jul 29, 2026
Drug recall: Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT)
Presence of Precipitate: medication was crystallizing and particles floating in the bottle — Rising Pharma Holding, Inc. · Class II · Ongoing · 74208 units
FDA Enforcement · Jul 29, 2026
Drug recall: Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%),…
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 1.033,266 cartons
FDA Enforcement · Jul 29, 2026
Drug recall: Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
FDA Enforcement · Jul 29, 2026
Drug recall: Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10…
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 353 cartons
FDA Enforcement · Jul 29, 2026
Device recall: FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of…
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator… — Boston Scientific Corporation · Class II · Ongoing · 74,760 units
FDA Enforcement · Jul 29, 2026
Device recall: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac…
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. — Boston Scientific Corporation · Class II · Ongoing · 6 units