FDA drug recalls

Hair was found in Naropin (ropivacaine hydrochloride) injection vials used for local anesthesia. The affected product is the 0.5% concentration in 20 mL single-dose vials. Approximately 92,600 vials from Lot #6133436 (expiration 10/2028) were distributed nationwide.

Hair was found in Fresenius Kabi Lidocaine HCl Injection vials (2%, 20 mg per mL). This affects 181,225 vials nationwide with lot number 6133801 and an expiration date of January 2028. No injuries have been reported.

Hair was found in some vials of Fresenius Kabi glycopyrrolate injection. The affected product is a prescription medication used during anesthesia and medical procedures. Two lots distributed nationwide are involved.

Rising Pharma's Cyproheptadine Hydrochloride Syrup (2 mg/5 mL, 473 mL bottles) is being recalled because the medication is crystallizing and forming particles that float in the bottle. This affects specific batches distributed nationwide. No injuries have been reported.

Rohto Cooling Eye Drops Cool Relief may not meet sterility standards required for eye medications. The affected product was manufactured in Vietnam and distributed nationwide. No injuries have been reported to date.

Rohto Cooling Eye Drops Dry Aid (twin pack) distributed nationwide may not meet sterility requirements. The affected lots were manufactured in Vietnam and distributed by The Mentholatum Company. No injuries have been reported.

Rohto Cooling Eye Drops Dry Aid may not meet sterility standards required for eye medications. The affected product was distributed nationwide. No injuries have been reported.

Rohto Cooling Eye Drops Digi Eye may not meet sterility standards required for eye products. The affected lots were distributed nationwide. No injuries have been reported.

Rohto Cooling Eye Drops Optic Glow may not meet sterility standards required for eye products. The manufacturer cannot confirm that certain batches were manufactured under proper sterile conditions. No injuries have been reported.

Rohto Cooling Eye Drops Max Strength (a nasal decongestant eye drop product) was distributed without assurance that all units met sterility standards. The product is used directly in the eye, where any contamination could pose a risk of infection. This recall affects specific lot numbers distributed nationwide.

Rohto Cooling Eye Drops Max Strength in certain lots may not be sterile. The manufacturer cannot assure that these drops meet sterility standards required for safe eye use. No injuries have been reported.

Rohto Cooling Eye Drops ALL-IN-ONE in specific lots does not meet sterility standards required for eye products. The issue was identified during manufacturing quality checks. Affected lots are distributed nationwide and are sold in pharmacies and retailers.

Asclemed USA Inc. is recalling Lidolog Kit, which contains lidocaine injection, because the label wrap covers the barcode, making it difficult to scan. This labeling defect affects 18 kits distributed in Tennessee.

Ascend Laboratories is recalling one lot of amlodipine and olmesartan medoxomil combination tablets (10 mg/20 mg) because the olmesartan medoxomil active ingredient is below the required amount. This means affected tablets may not work as intended to lower blood pressure.

Major Pharmaceuticals is recalling specific lots of levothyroxine sodium 150 mcg tablets because they contain less active ingredient than labeled. Levothyroxine is a thyroid hormone replacement medication, and subpotent tablets may not provide the intended therapeutic dose. The affected lots are lot #N02167A (bag) and lot #N02167 (blister), both expiring in July 2026.

Major Pharmaceuticals is recalling specific lots of Levothyroxine Sodium 125 mcg tablets because they may contain less active ingredient than labeled. Levothyroxine is a thyroid replacement medication, and tablets that are weaker than expected could result in inadequate thyroid hormone levels.

Major Pharmaceuticals issued a recall of Levothyroxine Sodium 75 mcg tablets because some batches do not contain the full labeled amount of active ingredient. This means the medication may not work as intended for treating thyroid conditions. The affected batches have expiration dates of July 2026 and December 2026.

Major Pharmaceuticals levothyroxine sodium 50 mcg tablets in certain lots contain less active ingredient than labeled, meaning they may not work as intended. This affects specific lot numbers expiring in October 2026 that were distributed nationwide.

Major Pharmaceuticals levothyroxine sodium 25 mcg tablets in certain lots do not contain the full labeled amount of active ingredient. This means the medication may not work as intended to treat thyroid conditions. The affected lots (N02212A, N02212B, and blister lot N02212, all expiring 07/2026) were distributed nationwide.

Major Pharmaceuticals is recalling one lot of levothyroxine sodium 150 mcg tablets because they do not contain the full stated dose of active ingredient. Patients taking this medication need the correct dose to manage their thyroid condition properly.

Major Pharmaceuticals is recalling one lot of Levothyroxine Sodium Tablets, USP 125 mcg due to subpotency—meaning the tablets contain less active ingredient than expected. This affects lot #N02266 with an expiration date of 11/2026. The affected tablets were distributed nationwide.

Major Pharmaceuticals issued a recall of Levothyroxine Sodium 112 mcg tablets (Lot #N02203, expiring 09/2026) because the medication is subpotent—meaning it contains less active ingredient than labeled. Patients taking this lot may not receive the full intended dose of this thyroid replacement medication.

Major Pharmaceuticals issued a recall of Levothyroxine Sodium Tablets, USP, 88 mcg (Lot #N02310, expiration 01/2027) because the tablets may contain less active ingredient than labeled. This means patients taking this medication may not receive the full intended dose of thyroid hormone.

Major Pharmaceuticals is recalling certain lots of Levothyroxine Sodium Tablets, USP, 75 mcg because they may contain less active ingredient than labeled. Patients taking affected tablets may not receive the full intended dose of this thyroid hormone medication.

Major Pharmaceuticals is recalling levothyroxine sodium 50 mcg tablets (lot N02200, expiration 10/2026) because they do not contain the full labeled dose. Levothyroxine is a thyroid hormone replacement medication, and a subpotent tablet may not provide the intended therapeutic effect for patients who depend on consistent dosing.

Major Pharmaceuticals is recalling one lot of Levothyroxine Sodium Tablets, USP, 25 mcg due to subpotency — meaning the tablets contain less active ingredient than labeled. This affects Lot N02212 with an expiration date of 07/2026. Patients taking subpotent levothyroxine may not receive the full intended dose of this thyroid hormone replacement medication.

Precision Dose Inc. is recalling one lot of Glycopyrrolate Oral Solution (1 mg/5 mL) due to an unidentified impurity found during routine stability testing that does not meet specification. The affected lot (506033) expires November 30, 2026. This medication is prescription-only and supplied in unit-dose oral syringes.

BD ChloraPrep Clear, a sterile skin antiseptic solution used before medical procedures, may have open or incomplete seals on individual applicator packaging. This could allow contamination of the sterile product. The issue affects multiple lot numbers distributed nationwide.

Chiesi USA is recalling specific lots of CLEVIPREX (clevidipine) injectable emulsion because the manufacturer cannot guarantee the vials are sterile. This affects vials distributed nationwide with lot numbers 1239521 and 1237454, expiring in October 2027. No injuries have been reported.

CAREone Carbamide Peroxide 6.5% oral rinse (lot 1505141, expiring April 2027) contains significantly less active ingredient than labeled (~0.6% instead of ~6.5%) and has a lower pH than specified. The product may not work as intended for its intended use.