Two Firms Recall Telmisartan, Amlodipine Tablets

Two firms have issued recalls for telmisartan and amlodipine tablets because samples failed 18-month stability testing, according to the April 17, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

Lupin Pharmaceuticals Inc. is recalling 12,504 bottles of 30-count telmisartan and amlodipine tablets, 80 mg/5 mg (NDC 68180-198-06), from lots G705843 (Exp. 4/19), G707763 (Exp. 8/19), and G800434 (Exp. 11/19). The affected bottles were sent to wholesalers, drug chains, and mail-order pharmacies that may have further distributed the tablets throughout the United States. 

AvKare Inc. is recalling 397 bottles of 30-count telmisartan and amlodipine tablets, 80 mg/5 mg (NDC 42291-795-30), from lots 201916 (8/19) and 20092 (Exp. 8/19). The recalled bottles were distributed in Arizona and Colorado. 

Lupin Pharmaceuticals voluntarily initiated the recall April 1, 2019. AvKare voluntarily issued its recall April 3, 2019. On April 11, 2019, the FDA designated both recalls Class III. According to the classification, use of the affected tablets is not likely to cause harm.

Telmisartan and amlodipine tablets are available with a prescription for the treatment of high blood pressure.

—Jolynn Tumolo