FDA drug recalls

Accord Healthcare is recalling specific lots of levothyroxine sodium 200 mcg tablets because they contain less active ingredient than labeled. This means the medication may not work as intended for patients taking it to treat thyroid conditions.

Accord Healthcare is recalling specific lots of Levothyroxine Sodium Tablets 175 mcg because they may contain less active ingredient than labeled. Levothyroxine is a thyroid hormone replacement medication, and tablets that are weaker than expected could result in inadequate treatment of thyroid conditions.

Accord Healthcare is recalling specific lots of levothyroxine sodium 150 mcg tablets because they may contain less active ingredient than labeled. Levothyroxine is a thyroid replacement medication, and subpotent tablets could result in inadequate thyroid hormone levels in patients who depend on this drug.

Subpotent Drug

Accord Healthcare is recalling specific lots of Levothyroxine Sodium 125 mcg tablets because they may contain less active ingredient than labeled. This means the medication may not work as intended for patients taking it to manage thyroid conditions.

Accord Healthcare is recalling specific lots of levothyroxine sodium 112 mcg tablets because they contain less active ingredient than labeled. This means patients taking these tablets may not receive the full thyroid hormone dose they need. The recall affects 1000-count bottles distributed nationwide.

Accord Healthcare is recalling certain batches of levothyroxine sodium 100 mcg tablets because they may contain less active ingredient than labeled. This affects patients who rely on consistent thyroid hormone dosing. The affected lots were distributed nationwide.

Accord Healthcare is recalling certain batches of levothyroxine sodium 88 mcg tablets because they may contain less active ingredient than labeled. This means the medication may not work as intended for patients who depend on it to manage thyroid conditions.

Accord Healthcare is recalling specific lots of levothyroxine sodium 75 mcg tablets because the tablets contain less active ingredient than labeled. Levothyroxine is a thyroid hormone replacement medication, and subpotent doses may not adequately treat thyroid conditions. The affected lots are D2402016 and D2402017, expiring 08/31/2026.

Accord Healthcare is recalling specific lots of levothyroxine sodium 50 mcg tablets because they contain less active ingredient than labeled. This means the medication may not work as intended for patients who depend on it to manage thyroid conditions.

Accord Healthcare is recalling specific lots of levothyroxine sodium tablets (25 mcg) because they contain less active ingredient than labeled. Patients taking these tablets may not receive the full dose needed to manage their thyroid condition. The affected lots were distributed nationwide.

American Regent's niCARdipine Hydrochloride Injection (25 mg/10mL) has been recalled due to contamination with particulate matter, including hair, glass, and/or paraformaldehyde. The affected lot (25295N0C0, expiring 04/30/2027) was distributed nationwide and affects approximately 43,460 vials.

American Regent's Tralement (trace elements injection) contains particulate matter including hair, glass, and/or paraformaldehyde. The contamination affects specific lots with expiration dates in April and September 2027. This is a prescription medication used in clinical settings.

American Regent's Papaverine HCl Injection (60 mg/2 mL) has been found to contain particulate matter identified as glass and/or paraformaldehyde. The contamination affects one lot (25202, expiring 11/30/2026) distributed nationwide. This is a prescription injectable medication used to treat certain circulatory conditions.

American Regent is recalling Multrys (Trace Elements Injection 4, USP) due to contamination with particulate matter, including hair, glass, and/or paraformaldehyde. The contamination was identified in specific lot 25163 (expiration 4/30/2027). This is a prescription intravenous medication used in hospitals and clinical settings.

American Regent's Selenious Acid Injection (a trace mineral used in intravenous nutrition) has been recalled because some vials contain particulate matter, including hair, glass, and/or paraformaldehyde. The contamination affects specific lot numbers distributed nationwide.

American Regent's acetylcysteine solution (20%, 200 mg/mL) in 4 mL vials has been found to contain particulate matter including hair, glass, and/or paraformaldehyde. The contamination affects two lots distributed nationwide. This is a prescription-only inhalation medication.

American Regent's acetylcysteine solution (10%, 100 mg/mL) in 4 mL vials has been found to contain particulate matter, including hair, glass, and/or paraformaldehyde. The contamination affects three specific lots distributed nationwide. This is a prescription medication for inhalation use only.

American Regent's Atropine Sulfate injection (1 mg/mL) has been found to contain particulate matter, including hair, glass, and/or paraformaldehyde. The contamination affects specific lot 24353 (expiration 9/30/2026). This is a prescription injectable medication used in hospitals and clinical settings.

American Regent's aminocaproic acid injection (250 mg/mL) has been recalled because batches contain particulate matter including hair, glass, and/or paraformaldehyde. The contamination affects 20 mL vials distributed nationwide. This is a prescription medication used to control bleeding.

American Regent's cyanocobalamin (vitamin B12) injection has been recalled due to contamination with particulate matter, including hair, glass, and/or paraformaldehyde. The affected product is a 10,000 mcg/10 mL multi-dose vial (Lot #25082, expiring 3/31/2027). This is a prescription medication administered by injection.

American Regent's Cyanocobalamin injection (vitamin B12) has been found to contain particulate matter, including hair, glass, and paraformaldehyde. The contamination affects specific lot numbers distributed nationwide. This is a prescription medication given by injection.

American Regent's nitroglycerin injection (50 mg/10 mL vials) has been found to contain particulate matter, including hair, glass, and/or paraformaldehyde. This affects lot #24291 with an expiration date of 8/31/2026, distributed nationwide. The contamination was discovered during quality testing.

Some Fresenius Kabi morphine sulfate prefilled syringes are labeled as morphine 2 mg/mL but actually contain Dilaudid (hydromorphone) 0.5 mg/0.5 mL. This labeling error could lead to patients receiving the wrong medication and dose. The affected lot is 6402820 with an expiration date of 12/2028.

Mylan Pharmaceuticals is recalling one lot of Acamprosate Calcium 333 mg delayed-release tablets because they failed to meet dissolution specifications—meaning the tablets may not break down and release the medication as intended in the body. This could result in ineffective treatment. No injuries have been reported.

Golden State Medical Supply is recalling Carbamazepine Tablets, USP 200mg due to black specks found in some tablets. This is a manufacturing quality issue. The affected lots were distributed nationwide.

Sun Pharmaceutical's Carbamazepine 200mg tablets (Lot #AD94033, expiring 5/31/2028) contain black spots caused by burnt ingredients during manufacturing. The tablets do not meet quality standards, though no injuries have been reported.

Regeneron is recalling one lot of Libtayo (cemiplimab-rwlc), an intravenous cancer treatment, because the manufacturer cannot guarantee the vials are sterile. This affects lot 8494000002, which expires July 31, 2028. About 21,353 vials are involved in the recall nationwide.

Certain vials of PEMRYDI RTU (pemetrexed injection) have shown green to dark green discoloration. The manufacturer received complaints from the field about affected vials. The discoloration may indicate a quality or sterility concern.

Certain vials of PEMRYDI RTU (pemetrexed injection) have developed green to dark green discoloration. The affected lots are P400172 and PA00050A, expiring 09/30/2027. Discoloration may indicate a quality issue with the medication.