FDA drug recalls

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.

Meijer's Carbamide Peroxide 6.5% oral rinse (0.5 FL OZ, lot 1505344, expiration April 2027) contains significantly less active ingredient than labeled — approximately 0.6% instead of the expected 6–7%. The product also has a lower pH than specified. This means the rinse will not work as intended for oral care.

Foster & Thrive Carbamide Peroxide 6.5% oral rinse was found to contain significantly less active ingredient than labeled (~0.6% instead of ~6-7%), along with abnormally low pH. The affected product may not work as intended for its intended use. No injuries have been reported.

Some bottles and kits of Leader Carbamide Peroxide 6.5% contain significantly less active ingredient than labeled (about 0.6% instead of 6–7%) and have an abnormally low pH. The product may not work as intended for ear wax removal or oral rinse.

Good Neighbor Pharmacy Carbamide Peroxide 6.5% ear-cleaning solution was distributed with significantly reduced active ingredient (~0.6% instead of ~6–7%) and abnormal pH. The product may not work as intended for ear wax removal.

Bell Pharmaceuticals' FAMILY Wellness Carbamide Peroxide 6.5% oral rinse has been found to contain significantly less active ingredient than labeled (~0.6% instead of ~6–7%), and has a lower pH than specified. The affected lots will not work as intended for oral care.

Bell Pharmaceuticals distributed Audiologist's Choice Carbamide Peroxide ear cleaning solution with significantly reduced active ingredient—about 0.6% instead of the expected 6–7%—and abnormally low pH. This makes the product ineffective for its intended use.

TopCare Health Carbamide Peroxide 6.5% oral rinse has significantly lower active ingredient than labeled (about 0.6% instead of 6–7%) and abnormal pH. The product may not work as intended for whitening or cleaning teeth.

QC Quality Choice Carbamide Peroxide 6.5% oral rinse has significantly lower active ingredient levels than labeled (about 0.6% instead of 6–7%) and an unusually low pH. This means the product may not work as intended for oral care. The recall affects specific lots distributed nationwide.

Bell Pharmaceuticals is recalling Clinere Carbamide Peroxide ear cleaning solution due to manufacturing defects that reduced the active ingredient strength to approximately 0.6% instead of the expected 6–7%. The affected bottles also have a lower-than-normal pH. These defects may reduce the product's effectiveness.

CVS Health Carbamide Peroxide 6.5% oral rinse contains significantly less active ingredient than labeled (about 0.6% instead of 6–7%) and has an abnormally low pH. The product may not work as intended for oral care.

Padagis Nystatin Cream USP (100,000 units, 15 g tube, lot #205060, expiring 09/30/2027) has been recalled because stability testing found the active ingredient fell below the required strength specification. The cream may not work as effectively as intended to treat fungal infections.

Cipla USA is recalling Cinacalcet Hydrochloride 90 mg tablets (lot 5PB0563, expiring 4/30/2027) because they contain elevated levels of N-nitroso-cinacalcet, a potentially harmful impurity that exceeds acceptable daily intake limits. This is a manufacturing quality issue.

Cipla USA is recalling certain batches of Cinacalcet Hydrochloride 60 mg tablets because they contain N-nitroso-cinacalcet, a chemical impurity, at levels above the FDA's acceptable daily intake. The affected lots were distributed nationwide. No injuries have been reported.

Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 30 mg tablets because they contain elevated levels of N-nitroso-cinacalcet, a manufacturing impurity that exceeds FDA safety limits. The affected bottles were distributed nationwide.

Lannett Company distributed amphetamine extended-release capsules that contained only immediate-release pellets but were labeled as extended-release. This labeling error could result in incorrect dosing and medication timing for patients who depend on the extended-release formulation.