Posted January 30, 2009

Generic Toprol XL (Metoprolol Succinate ER) Recalled Along with 60 Other Drugs

On January 28, 2009, ETHEX Corporation, a subsidiary of KV Pharmaceutical, announced a nationwide recall at the retail level of all strengths of Metoprolol Succinate ER tablets (25 mg, 50 mg, 100 mg and 200 mg). ETHEX issued the recall as a precautionary measure because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs). In December, 2008 KV had announced that it suspended production of Metoprolol Succinate ER products but, at that time, did not recall products.

ConsumerLab.com reported on potential performance issues with generic Toprol XL products in March, 2008. [See ConsumerLab.com Drug Investigation of Metoprolol Succinate ER.

In August, 2008, the FDA sent a Warning Letter regarding generic Metoprolol Succinate ER made by another manufacturer, Sandoz [See 8/28/2008 posting on ConsumerLab.com in archive below]. Although not widely announced, in September and November 2008 Sandoz recalled its Metoprolol Succinate ER products.

Due to the recalls by ETHEX and Sandoz, many pharmacies are currently out-of-stock of the products and are also low on brand name Toprol XL. PharmacyChecker.com, a sister company of ConsumerLab.com, has reported that Toprol XL may be purchased from licensed pharmacies in other countries, where it is sold under different trade names and at lower prices, which can be found on the www.PharmacyChecker.com website.

As part of the new recall, ETHEX is also recalling, to the wholesale level, 60 other generic products. A full list of these products and more information about the recall is found at the link below.