FDA drug recalls

Teva Pharmaceuticals is recalling specific lots of Octreotide Acetate injectable suspension due to sterility concerns identified at the manufacturing facility. The FDA found quality system deficiencies that could affect the safety of the medication.

Macleods Pharma USA is recalling Levothyroxine Sodium Tablets USP 150 mcg because they may contain less active ingredient than labeled. This means the medication may not work as intended to treat thyroid conditions. The affected lot is 16240062A with an expiration date of March 2026.

Chiesi USA is recalling specific lots of CUROSURF, a medication given to premature infants to help them breathe. The company cannot confirm that all vials are sterile, which means they may be contaminated. No infections have been reported so far.

Radnostix Gelatin Capsule Packs used with Sodium Iodide I-131 Kit have failed quality specifications. The affected capsules may not perform as intended. Three specific lots distributed nationwide are involved.

Apotex Corp. is recalling specific lots of brimonidine tartrate/timolol maleate eye drops because the manufacturer cannot confirm the product was sterilized properly. The affected lots are VJ8599 (expires 09/30/2026) and VL1668 (expires 01/31/2027). No infections or injuries have been reported so far.

Somerset Therapeutics is recalling one lot of dexamethasone sodium phosphate injection because testing found impurity levels above acceptable limits as the product approached its expiration date. The affected lot (A240421, expiring 07/31/2026) was distributed nationwide. No injuries have been reported.

A 1 mg Pitavastatin tablet was found mixed into a bottle labeled as containing 2 mg tablets. This occurred in one lot (A252487) distributed in Tennessee. Taking the wrong dose by mistake could affect how well your cholesterol medication works.

Strides Pharma Children's Ibuprofen Oral Suspension (100 mg per 5 mL) has been recalled because some bottles contain gel-like masses and black particles. The affected bottles are 4 FL OZ (120 mL) size with lot numbers 7261973A or 7261974A, expiring 01/31/2027. No injuries have been reported.

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

Mylan Pharmaceuticals is recalling specific lots of Amnesteem (isotretinoin) 40 mg capsules because they failed to meet dissolution specifications—meaning the medication may not break down and be absorbed by your body as intended. This could affect how well the medicine works. The recall affects two lots (3116110 and 3116130) with an expiration date of July 2026.

MR. 7 SUPER 700000 capsules contain hidden prescription drugs—sildenafil and tadalafil—that are not listed on the label. These are serious medications that can interact with other drugs and cause health problems. The product was sold without FDA approval.

Mojo Max Fusion XXX capsules contain hidden prescription drugs—sildenafil and tadalafil—that were not listed on the label. These are potent medications that can cause serious health problems, especially if you take other drugs or have certain heart or blood pressure conditions. The FDA has not approved this product for sale.

New Life Pharma LLC is recalling one lot of Tirzepatide 15mg injection due to lack of assurance of sterility. The affected lot (240709) was distributed in Ohio. No injuries have been reported.

New Life Pharma LLC is recalling Tirzepatide 10mg multi-dose vials (Lot 240709, expiration 7/31/2026) because the manufacturer cannot confirm the product is sterile. The vials were distributed in Ohio. No injuries have been reported.

New Life Pharma is recalling Nomida semaglutide 2 mg injection vials because the sterility of the product cannot be assured. The affected vials may not be safe to use. This recall affects a limited quantity distributed in Ohio.

New Life Pharma LLC is recalling specific lots of semaglutide injection (Nomida brand) because the company cannot confirm the medication was made under sterile conditions. The affected lots are 241113 (expires 11/30/2026) and 250103 (expires 1/31/2027). A total of 820 vials were distributed in Ohio.

Radnostix Sodium Iodide (I-131) Solution, a prescription oral therapeutic medication, is being recalled because some vials contain particulate matter due to production issues. The affected medication is in 1 ml, 2 ml, and 3 ml vials with batch number I012626R-01 and expiration date 02/09/2026. No injuries have been reported.

SILINTAN 25 pills, sold in 25-count bottles, contain an undeclared ingredient called meloxicam, a prescription pain reliever. The FDA found this ingredient was not listed on the label and the product was not approved by the FDA. The recall affects all lots currently in use.

HTO Nevada Inc. (doing business as Kirkman) is recalling one lot of Maximum Zone 2 4% Lidocaine Cream because stability testing does not support the printed expiration date. The product may lose strength or safety before the labeled date.

Kirkman's Maximum Zone 1 4% Lidocaine Cream (1/2 oz bottles) is being recalled because stability testing does not support the listed expiration date of July 31, 2026. This means the product may not maintain its intended strength and safety beyond an earlier date. The recall affects lot #807CP-0003 distributed nationwide.

Kirkman's FIVE-STAR VASOCAINE Spray (a local anesthetic spray) is being recalled because the manufacturer's stability testing does not support the printed expiration dates on the bottles. This means the product may degrade or become less effective before the labeled date. Nine lots distributed nationwide are affected, with expiration dates ranging from March 2026 to July 2028.

Rising Pharmaceuticals is recalling specific bottles of Temozolomide 5mg capsules because testing found the medication didn't meet quality standards for purity and stability. The issue was discovered during routine 9-month stability testing. This affects 1,200 bottles distributed nationwide with expiration date 09/2026.

Major Pharmaceuticals is recalling midodrine hydrochloride 5 mg tablets (Lot N02640, expiring 08/2027) because some blister packages are not properly sealed. Defective packaging could allow the medication to degrade or become contaminated. No injuries have been reported.

Cipla USA is recalling Nilotinib 200 mg capsules (Lot 5GJ0223, expiring 04/30/2027) because the capsules failed quality tests during stability testing. The capsules may not meet appearance and description standards, which means their safety and effectiveness cannot be guaranteed.

Cipla USA is recalling specific lots of Nilotinib 150 mg capsules because testing found the capsules did not meet appearance and description standards after six months of storage. The affected lots are 5GJ0220, 5GJ0221, and 5GJ0222, with expiration date 04/30/2027. No injuries have been reported.

The FDA is recalling semaglutide powder distributed by Harbin Jixianglong Biotech for compounding use only. The manufacturer did not complete required manufacturing process and bacterial endotoxin testing before shipping the product. This was a manufacturing oversight, not a confirmed safety incident.

Harbin Jixianglong Biotech distributed semaglutide (an injectable medication for compounding) without completing required manufacturing process and bacterial endotoxin testing. This means the drug may not meet safety and purity standards. The affected lot is CP-030-20250711 with an expiration date of July 24, 2027.

ACME United Corporation's antimicrobial alcohol hand wipes (70% isopropyl alcohol) are being recalled because the manufacturer did not follow proper quality and safety procedures during production. Multiple lot numbers with expiration dates ranging from April 2027 to January 2028 are affected. No injuries have been reported.

The FDA identified manufacturing quality deviations (CGMP violations) in three lots of Children's Healthcare of Atlanta instant hand sanitizing wipes. These wipes may not meet quality and safety standards. The affected lots were distributed nationwide.

Dynarex BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) in 1000-packet boxes were manufactured with deviations from FDA quality standards. Affected lots are 53518 and 53519, with expiration dates of June 2027. The products were distributed nationwide.