FDA drug recalls

The FDA recommended a recall of MGC Health Menthol Cough Drops (Sugar Free, Honey Lemon) after inspecting the manufacturing facility on August 15, 2025, and identifying quality control issues. The recall affects three specific product lots distributed nationwide.

The FDA inspected the manufacturing facility for these cough drops on August 15, 2025, and found observations that may affect product quality. The affected product is a 30-count bag of Discount Drug Mart menthol cough drops (Lot #20241030, expiring 10/30/2026) distributed nationwide.

The FDA inspected the manufacturing facility for these honey lemon menthol cough drops on August 15, 2025, and found observations that may affect product quality. The affected product is a 30-count bag with lot number 20241030 and expiration date 10/30/2026, distributed nationwide.

The FDA inspected the manufacturing facility for Caring Mill menthol cough drops on August 15, 2025, and found observations that raised concerns about product quality. The manufacturer is recalling the product out of caution. No injuries have been reported.

The FDA recommended a recall of Exchange Select menthol cough drops after inspecting the manufacturing facility in China on August 15, 2025, and finding observations that may affect product quality. The affected product is a 30-count bag with lot number 20241030 and expiration date 10/30/2026.

The FDA found quality concerns at the manufacturing facility during an inspection on August 15, 2025. Exchange Select menthol cough drops (30-count bags, lot #20241030, expiring 10/30/2026) sold at military exchanges may be affected. No injuries have been reported.

SLMD Benzoyl Peroxide Acne Lotion 2.5% in 0.7 fl. oz and 1.5 fl. oz bottles has been found to contain benzene, a chemical that should not be present in this product. This affects approximately 2,500 bottles distributed nationwide. No injuries have been reported.

Sandra Lee MD's SLMD BP Acne Spot Treatment (10% Benzoyl Peroxide) has been recalled because it contains benzene, a harmful chemical. The affected product is sold in 0.5 fl. oz bottles with lot numbers 2567200 (expires 8/1/26) or 2691600 (expires 10/30/2027). No injuries have been reported.

HydroPeptide Clear Alliance Serum (2.5% benzoyl peroxide) contains benzene, a harmful chemical not intended in the product. The affected bottles are 1 FL OZ and 2 FL OZ sizes with lot numbers 2518800 and 2518900. No injuries have been reported, but the FDA has issued a recall due to potential health risks from benzene exposure.

FarmHouse Fresh Midnight Clearing night lotion (2.5% benzoyl peroxide) contains benzene, a harmful chemical not meant to be in this product. The contamination was found in three specific lot numbers. No injuries have been reported so far.

Cipla USA is recalling certain batches of cinacalcet 90 mg tablets because they contain higher-than-safe levels of a chemical impurity called N-Nitroso Cinacalcet. The affected bottles were distributed nationwide. No injuries have been reported.

Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 60 mg tablets because they contain higher-than-acceptable levels of N-Nitroso Cinacalcet, a nitrosamine impurity. This impurity can pose a health risk with long-term exposure. The affected lots were distributed nationwide.

Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 30 mg tablets because they contain higher-than-acceptable levels of a chemical impurity called N-Nitroso Cinacalcet. The affected tablets were distributed nationwide. This is a manufacturing quality issue; no injuries have been reported.

Teva Pharmaceuticals is recalling specific batches of Clonidine Transdermal System patches (0.3 mg/day) because they were manufactured using an unapproved raw material that does not meet quality standards. The affected patches were distributed in the U.S. No injuries have been reported.

Teva Pharmaceuticals is recalling specific lots of Clonidine Transdermal System (0.2 mg/day) patches because they were made with an unapproved raw material that does not meet manufacturing standards. Two lots are affected: 100060002 (expires 07/2026) and 100066802 (expires 05/2027). No injuries have been reported.

Teva Pharmaceuticals is recalling certain Clonidine Transdermal System patches (0.1 mg/day) because they were manufactured using an unapproved raw material that does not meet FDA standards. The affected patches were distributed in the U.S. The company and FDA are working to ensure the product is removed from use.

GE Healthcare discovered particles in certain vials of Omnipaque (iohexol), a contrast dye used during medical imaging procedures. The contamination affects 11 specific lot numbers distributed nationwide. No injuries have been reported so far.

GE Healthcare has recalled specific lots of Omnipaque (iohexol) injection, a contrast dye used in medical imaging, because some vials may contain visible particles. This could affect the safety of the procedure if the contaminated solution is used.

Teva Pharmaceuticals is recalling certain batches of Isotretinoin 40 mg capsules because some capsules may be too strong (superpotent) or too weak (subpotent). This medication is a prescription acne treatment that requires precise dosing. The affected batches were distributed in Florida, Ohio, Puerto Rico, and Mississippi.

Teva Pharmaceuticals is recalling specific lots of Isotretinoin 30 mg capsules because some capsules may contain too much active ingredient (superpotent) while others may contain too little (subpotent). This inconsistency could affect how well the medication works or increase the risk of side effects.

Viatris is recalling one lot of Xanax XR (alprazolam) 3 mg extended-release tablets because they failed to meet dissolution specifications—meaning the tablets may not break down and release the medication properly in your body. This affects only lot #8177156 with an expiration date of 02/28/2027, distributed nationwide. No injuries have been reported.

Preferred Pharmaceuticals' Artificial Tears Lubricant Eye Drops in 0.5 oz bottles may not be sterile due to a manufacturing issue. The FDA is recalling specific lots because sterility cannot be assured. No injuries have been reported.

Fagron Compounding Services is recalling specific lots of Vancomycin HCL injections due to two safety concerns: the bags may not be sterile, and a blue plastic part on the administration port could detach during use. The recall affects over 11,600 bags distributed nationwide.

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Fagron Compounding Services is recalling norepinephrine bitartrate injection due to two issues: the sterility of the product cannot be assured, and a blue plastic part on the administration port may detach during use. This medication is used in hospitals and medical facilities to treat critical conditions. Six specific lots distributed nationwide are affected.

Fagron Compounding Services is recalling specific lots of norepinephrine bitartrate injection due to two concerns: the product may not be sterile, and a blue plastic piece on the administration port could detach during use. This medication is used in hospitals and clinical settings to support blood pressure in critically ill patients.

Fresenius Kabi USA is recalling a specific batch of 5% Dextrose Injection due to concerns that the product may not meet sterility standards. This injectable solution is used in medical settings to deliver fluids and glucose to patients. The affected batch (6402165, expiring 05/30/2028) was distributed nationwide.

Fresenius Kabi is recalling specific batches of 5% Dextrose Injection because the company cannot guarantee the product is sterile. This intravenous solution is used in hospitals and medical settings. The affected batches have expiration dates of February 28, 2027.

Fresenius Kabi is recalling a specific batch of 5% Dextrose Injection due to lack of assurance of sterility. The affected product is in 50 mL freeflex bags. This intravenous medication was distributed nationwide, including Alaska and Puerto Rico.