FDA drug recalls

Testing found that Allies Group THE ONE SPF 50 Invisible Sunscreen Gel may not provide the advertised SPF 50 sun protection. The product was distributed nationwide in the U.S. The affected sunscreen was made in the U.S.A and distributed by Allies Group Pte Ltd.

Testing found that THE ONE SPF 50 Invisible Sunscreen Gel sachets may not provide the SPF 50 sun protection stated on the label. The affected product was distributed nationwide in the U.S. No injuries have been reported.

Testing by Allies Group Inc. found that The One SPF 50 Invisible Sunscreen Gel may not provide the full SPF 50 sun protection stated on the label. The affected product was distributed nationwide in the U.S. across multiple lot codes with expiration dates through June 2029.

Bionpharma Inc. is recalling Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets (10 mg/10 mg, 100-count bottles) because some bottles contain unidentified foreign tablets or capsules mixed in with the correct medication. The affected lot is DMA25006 with an expiration date of 11/30/2028. This issue was discovered during quality control.

Baxter Healthcare is recalling one lot of Daptomycin in 0.9% Sodium Chloride Injection due to deviations from current good manufacturing practice (CGMP) standards during production. The affected lot (NC193856, expiring 04/18/2028) was distributed nationwide, Puerto Rico, and Chile.

Baxter Healthcare Corporation is recalling one lot of Vancomycin Injection (NDC 0338-3583-01, Lot #NC193894) due to deviations from good manufacturing practices (CGMP). The affected lot was distributed nationwide in the US, Puerto Rico, and Chile.

Baxter Healthcare Corporation is recalling three lots of Vasopressin injection due to manufacturing process deviations that do not meet FDA quality standards. The affected lots were distributed nationwide, in Puerto Rico, and Chile. No injuries have been reported.

Baxter Healthcare Corporation is recalling one lot of Clindamycin Injection USP in 5% Dextrose due to deviations from manufacturing quality standards. The affected lot was distributed nationwide, in Puerto Rico, and Chile.

Baxter Healthcare Corporation is recalling one lot of Clindamycin Injection USP in 5% Dextrose (900 mg/50 mL) due to deviations from current good manufacturing practices (CGMP). The affected lot was distributed nationwide, in Puerto Rico, and Chile. No injuries have been reported.

Baxter Healthcare Corporation is recalling a specific lot of Clindamycin Phosphate in 0.9% Sodium Chloride Injection due to deviations from current Good Manufacturing Practice (CGMP) standards during production. The affected lot (NC193689, expiring 10/16/2027) was distributed nationwide, as well as to Puerto Rico and Chile.

Baxter Healthcare has recalled three specific lots of Clindamycin Injection USP (900 mg per 50 mL) due to deviations from Good Manufacturing Practice (CGMP) standards during production. The affected lots were distributed nationwide, Puerto Rico, and Chile. No injuries have been reported.

Baxter Healthcare has recalled multiple lots of Nexterone (amiodarone HCI) injection due to deviations from good manufacturing practices (CGMP) during production. The affected lots were distributed nationwide, Puerto Rico, and Chile. No injuries have been reported.

Baxter Healthcare has recalled specific lots of CARDENE IV (nicardipine hydrochloride) injection due to deviations from manufacturing quality standards. The affected lots were distributed in the United States, Puerto Rico, and Chile.

Baxter Healthcare Corporation is recalling one lot of Pantoprazole Sodium in 0.9% Sodium Chloride Injection due to deviations from current good manufacturing practices (CGMP). The affected lot was distributed in the United States, Puerto Rico, and Chile.

Baxter Healthcare is recalling specific lots of Vasopressin injection due to deviations from manufacturing standards (CGMP). The affected lots may not meet required quality and purity standards. This is a precautionary recall of a medication used in hospitals and clinical settings.

Baxter Healthcare Corporation is recalling specific lots of dexmedetomidine hydrochloride injection due to deviations from current good manufacturing practice (CGMP) standards during production. The affected lots were distributed nationwide, in Puerto Rico, and Chile.

Baxter Healthcare is recalling two lots of famotidine injection (20 mg in 50 mL sodium chloride) due to deviations from manufacturing standards. The affected lots may not meet quality and sterility requirements.

Baxter Healthcare Corporation is recalling specific lots of Clindamycin Injection USP in 5% Dextrose due to deviations from current Good Manufacturing Practice (CGMP) standards during production. The affected lots are NC193764 (expiration 10/18/2027) and NC195232 (expiration 11/25/2027), distributed nationwide in the US, Puerto Rico, and Chile.

Baxter Healthcare is recalling one lot of Daptomycin in 0.9% Sodium Chloride Injection due to deviations from good manufacturing practices (CGMP) during production. The affected lot (NC188692, expiring 11/22/2027) was distributed nationwide, in Puerto Rico, and Chile. No injuries have been reported.

Baxter Healthcare is recalling specific lots of MYXREDLIN (insulin human injection) due to deviations from current Good Manufacturing Practice (CGMP) standards during production. The affected lots were distributed in the US, Puerto Rico, and Chile. No injuries have been reported.

Baxter Healthcare Corporation is recalling five lots of Vancomycin Injection USP in 5% Dextrose due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The affected lots were distributed nationwide, in Puerto Rico, and Chile.

Golden State Medical Supply Inc. is recalling Prasugrel HCI 10mg tablets (lot GS062298, expiration 09/30/2026) because they failed to meet dissolution specifications during quality testing. Dissolution is how quickly a tablet breaks down in the body to release its active ingredient. Tablets that dissolve too slowly or incompletely may not work as intended.

B. Braun Medical has recalled Lactated Ringer's Injection USP in 1000 mL EXCEL containers due to the presence of particulate matter. The affected lot is J4H077 with an expiration date of November 30, 2026. About 23,688 bags were distributed nationwide.

Hikma Pharmaceuticals is recalling specific lots of Ramipril Capsules 10 mg because testing found higher-than-allowed levels of dicyclohexylurea, a process impurity. The affected lots are AC5470A and AC5470B, both expiring July 2027. No injuries have been reported.

Fresenius Kabi USA discovered that Tyenne (tocilizumab-aazg) Injection vials may contain glass particles. The contamination was found during an internal investigation. The affected lot is 16UI07, which expires August 31, 2028.

Apotex Corp. is recalling one lot of Paxil CR (paroxetine) 37.5mg extended-release tablets because the medication failed to meet dissolution specifications during 24-month stability testing. This means the tablets may not release the drug into the body as intended. The affected lot (TY9494, expiration 05/31/2027) was distributed nationwide.

Mallinckrodt has recalled specific lots of Acthar Gel (repository corticotropin injection) due to the presence of glass and stopper pieces in the vials. This contamination could pose a risk if the affected medication is used. The recall affects 12,367 vials with lot numbers 1564-107 and 1564-107H, both expiring January 31, 2027.

FDA inspection found that Zicam Cold Remedy Medicated Nasal Swabs failed microbiological testing, meaning they may contain harmful microbes. The affected products were manufactured under conditions that did not meet federal safety standards. Specific lot numbers with expiration dates through August 2028 are involved.

Lupin Pharmaceuticals is recalling specific lots of Clobetasol Propionate Cream USP 0.05% because the active ingredient is not uniformly distributed throughout the product. This means some parts of the cream may contain too much or too little medication, which could affect how well it works.

Accord Healthcare is recalling one lot of Levothyroxine Sodium 300 mcg tablets because they may contain less active ingredient than labeled. Levothyroxine is a thyroid medication, and subpotent tablets may not work as intended to treat thyroid conditions.