FDA drug recalls

Fresenius Kabi USA is recalling a specific batch of 0.9% Sodium Chloride Injection (a sterile saline solution used in medical settings) because the manufacturer cannot guarantee it remained sterile during production. The affected batch (24EU10010) was distributed nationwide, including Alaska and Puerto Rico.

Fresenius Kabi is recalling specific batches of 0.9% sodium chloride injection (saline) in 1,000 mL freeflex bags due to lack of assurance of sterility. The affected batches were distributed nationwide, including Alaska and Puerto Rico. No injuries have been reported.

Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection (saline solution) used in medical settings because the manufacturer cannot guarantee the product is sterile. The affected batches were distributed nationwide. No injuries have been reported so far.

Lack of Assurance of Sterility

Fresenius Kabi USA is recalling specific batches of 0.9% Sodium Chloride Injection (a sterile saline solution) because the manufacturer cannot guarantee the product is free from contamination. The affected batches were distributed nationwide, including Alaska and Puerto Rico, between now and June 2027.

Fresenius Kabi USA is recalling specific batches of 0.9% Sodium Chloride Injection (saline) because the manufacturer cannot confirm the product is sterile. Sterility is critical for injectable medications. The affected batches have expiration dates of October 31, 2026, or November 30, 2026.

Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection due to a lack of assurance that the product is sterile. This injectable solution is used in medical settings and could pose a risk if contaminated. No injuries have been reported to date.

Fresenius Kabi USA is recalling multiple batches of 0.9% Sodium Chloride Injection (saline solution) used for medical purposes because the manufacturer cannot guarantee the product is sterile. The affected batches were distributed nationwide, Alaska, and Puerto Rico. No injuries have been reported.

Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection (saline) in 100 mL bags due to lack of assurance of sterility. The affected batches were distributed nationwide, including Alaska and Puerto Rico. No injuries have been reported.

Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection because the manufacturer cannot guarantee these vials are sterile. This injectable medication is used in hospitals and clinical settings. No injuries have been reported.

Fresenius Kabi is recalling one batch of 0.45% sodium chloride injection (saline solution) used in hospitals and medical facilities because the manufacturer cannot guarantee the product is sterile. The affected batch is #6402413 with an expiration date of 02/29/2028. No infections or injuries have been reported so far.

Cipla USA is recalling specific lots of Lanreotide Injection (120 mg) because the manufacturer did not follow proper visual inspection procedures during production. This means the medication may not meet sterility standards and could potentially be contaminated.

Cipla USA is recalling specific lots of Lanreotide Injection 120 mg due to concerns about sterility. The FDA found deficiencies in the manufacturer's visual inspection procedures, which could mean some syringes may not be properly sterilized. No injuries have been reported so far.

Some cartons of Amneal Magnesium Sulfate IV bags were mislabeled and contained Tranexamic Acid (a different medication) instead. This mix-up affects lot AH250162 with an expiration date of 8/31/2027. The error was discovered before the product reached patients.

Appco Pharma LLC is recalling specific lots of prazosin hydrochloride 5mg capsules because they contain higher-than-acceptable levels of a nitrosamine impurity (N-nitroso-prazosin). Nitrosamines are chemical contaminants that may increase health risks with long-term exposure. This is a manufacturing quality issue, not a safety defect in the drug itself.

Appco Pharma LLC is recalling specific lots of prazosin hydrochloride 2mg capsules because they contain higher-than-allowed levels of a nitrosamine impurity called N-nitroso-prazosin. Nitrosamines are chemicals that may increase cancer risk with long-term exposure. No injuries have been reported so far.

Appco Pharma LLC is recalling prazosin hydrochloride 1mg capsules (100-count bottles) because they may contain higher-than-acceptable levels of a nitrosamine impurity. This impurity was detected during manufacturing quality checks. The recall affects specific lot numbers distributed nationwide.

Multiple brands of artificial tears eye drops made by K.C. Pharmaceuticals have been recalled because the manufacturer cannot confirm the product is sterile. The affected drops are sold under store brands including Leader, Good Sense, Good Neighbor Pharmacy, TopCare, Best Choice, Kroger, Publix, and Quality Choice. No injuries have been reported.

K.C. Pharmaceuticals issued a recall of Rugby Lubricating Eye Drops and Walgreens Lubricant Eye Drops because the manufacturer cannot guarantee the products are sterile. Non-sterile eye drops can introduce bacteria or other microorganisms into the eye. The recall affects specific lots (SY24K01 and SY24K02) with expiration dates of 09/30/26.

K.C. Pharmaceuticals has recalled multiple brands of sterile redness relief eye drops because they may not meet sterility standards. The affected products were distributed nationwide under various store and pharmacy brand names. No injuries have been reported so far.

K.C. Pharmaceuticals issued a recall of sterile eye drops sold under multiple brand names (including Walgreens, Good Sense, Kroger, CVS, and others) because the manufacturer cannot confirm the products remain sterile. The affected bottles were distributed nationwide. No injuries have been reported.

K.C. Pharmaceuticals is recalling multiple brands of ultra lubricating eye drops sold nationwide because the manufacturer cannot guarantee the drops are sterile. The affected products were distributed under names including Leader, Harris Teeter, Foster & Thrive, Walgreens, CVS Health, Kroger, Publix, Meijer, Good Sense, Quality Choice, and Avenova. No injuries have been reported.

K.C. Pharmaceuticals is recalling Dry Eye Relief Eye Drops sold under multiple store brands including Geri Care, TopCare, Rite Aid, Leader, and others due to concerns that the product may not be sterile. The recall affects 15 mL bottles with specific lot numbers and expiration dates sold nationwide.

K.C. Pharmaceuticals' Advanced Relief eye drops in 0.5 fl oz bottles may not be sterile due to a manufacturing issue. The affected products were sold under multiple store brands at Walgreens, Kroger, CVS, and other retailers nationwide. No infections have been reported so far.

K.C. Pharmaceuticals has recalled multiple brands of sterile eye drops (including Best Choice, Quality Choice, Discount Drug Mart, Good Sense, Walgreens, CareOne, Equaline, TopCare, Meijer, and H.E.B.) because the manufacturer cannot guarantee the products are sterile. Non-sterile eye drops can introduce infection into the eye. The affected products were distributed nationwide and have lot number AC24E01 with expiration date 05/31/26.

Amneal Pharmaceuticals is recalling specific lots of tramadol 50 mg tablets because they contain higher-than-allowed levels of a chemical impurity called N-nitroso-desmethyl-tramadol (NDSRI). The impurity was discovered during stability testing of tablets nearing the end of their shelf life. No injuries have been reported.

Alembic Pharmaceuticals is recalling specific lots of Bromfenac Ophthalmic Solution 0.07% because the medication failed purity and degradation tests during stability testing at 20 months. The affected eye drops may contain higher-than-acceptable impurity levels, which could affect safety and effectiveness.

American Health Packaging is recalling specific batches of Meclizine Hydrochloride 12.5 mg tablets because they failed to meet required tablet specifications. The affected product is Lot #1024852 with an expiration date of 9/30/2026. No injuries have been reported.

Teva Pharmaceuticals is recalling specific lots of Octreotide Acetate 30 mg injectable suspension due to quality control problems found at the manufacturer. The FDA identified deficiencies that mean the sterility of these vials cannot be guaranteed. No injuries have been reported.

Teva Pharmaceuticals is recalling specific lots of Octreotide Acetate injectable suspension (20 mg) due to quality control issues at the manufacturing facility in Greece. The FDA found deficiencies that could affect sterility—the assurance that the medication is free from harmful bacteria and other microorganisms.