Diabetes Drug Tablets Recalled

Direct Rx is recalling glimepiride tablets in several strengths, according to the April 5, 2023, US Food and Drug Administration (FDA) Enforcement Report. The report cites deviations from Current Good Manufacturing Practices but provides no other specifics behind the reason for the recall.

The recall affects the following products, which were packaged and distributed throughout the United States by Direct Rx, Dawsonville, Georgia:

• 1-mg glimepiride tablets in 30-count bottles (NDC 61919-0723-30) from lot 07MA2208 (Exp 5/31/24);
• 1-mg glimepiride tablets in 90-count bottles (NDC 61919-0723-90) from lots 09AU2128 (Exp 1/31/24), 28JY2102 (Exp 1/31/24), 06AU2103 (Exp 1/31/24), 03JA2210 (Exp 1/31/24), 14JY2114 (Exp 1/31/24), 05NO2106 (Exp 2/29/24), 13OC2118 (Exp 2/29/24), and 08DE2121 (Exp 2/29/24);
• 2-mg glimepiride tablets in 30-count bottles (NDC 61919-0488-30) from lot 21JU2112 (Exp 9/30/23);
• 2-mg glimepiride tablets in 90-count bottles (NDC 61919-0448-90) from lots 22DE2113 (Exp 1/31/24), 27JA2235 (Exp 3/31/24), 05AP2224 (Exp 7/31/24), 06AU2104 (Exp 1/31/24), 08JU2215 (Exp 9/30/24), 209AU2109 (Exp 1/31/24), 15JU2113 (Exp 9/30/23), 21FE2217 (Exp 4/30/24), 21OC2115 (Exp 2/29/24), 23JY2144 (Exp 1/31/24), 25JU2124 (Exp 9/30/23), 29AP2219 (Exp 7/31/24), and 07DE2128 (Exp 3/31/24);
• 4-mg glimepiride tablets in 30-count bottles (NDC 61919-0250-30) from lot 13DE2111 (Exp 3/31/24); and
• 4-mg glimepiride tablets in 90-count bottles (NDC 61919-0250-90) from lots 17NO2116 (Exp 1/31/24), 27JA2234 (Exp 4/30/24), 02MA2218 (Exp 6/30/24), 12MY2211 (Exp 7/31/24), 13JY2107 (Exp 10/31/23), 15AP2221 (Exp 7/31/24), 17AU2110 (Exp 10/31/23), 20SE2108 (Exp 10/31/23), 23JU2115 (Exp 10/31/23), 28JY2101 (Exp 10/31/23), 30JY2101 (Exp 10/31/23), 05JA2212 (Exp 3/31/24), 13DE2130 (Exp 3/31/24), 21OC2111 (Exp 1/31/24), and 17NO2116 (Exp 3/31/24).

Direct Rx voluntarily initiated the recall March 13, 2023. On March 24, 2023, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Glimepiride is a prescription medication used with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.