Amneal Pharmaceuticals recalls

Amneal Pharmaceuticals is recalling specific lots of Estradiol Gel 0.1% because some packets in affected cartons were found to be empty or only partially filled. This means patients may not receive the correct dose of medication. The recall affects 2,592 cartons distributed nationwide.

Moderate·FDA·Oct 7, 2026

Some prefilled pens of Amneal Exenatide Injection may contain no medication due to a defective delivery system. This affects lot AP250095A (expiration 2/28/2027). Patients relying on these pens may not receive their intended dose.

Moderate·FDA·Sep 30, 2026

Amneal Pharmaceuticals is recalling Primidone 50 mg tablets (NDC 53746-544-01, lot AM251676) due to potential cross-contamination with Acemetacin during manufacturing at the API supplier. The contamination could affect the safety or effectiveness of the medication.

Moderate·FDA·Jun 17, 2026

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.

Serious·FDA·Apr 8, 2026

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.

Moderate·FDA·Apr 8, 2026

One lot of Amneal Magnesium Sulfate in Water for Injection IV bags was found to contain the wrong medication—Tranexamic Acid—inside the packaging. This mix-up affects hospitals that received the product between late December 2025 and late February 2026. No patients have been harmed so far.

Serious·FDA·Mar 24, 2026