Tolmar, Inc. initiated a recall of ELIGARD (leuprolide acetate) for injectable suspension on September 12, 2023. The recall, identified as D-1178-2023, was classified as Class III by the FDA. The stated reason was superpotent drug levels, with higher than expected concentrations of leuprolide acetate found in the constituted product. The affected product is the 7.5 mg monthly formulation, NDC 62935-753-75, manufactured by Tolmar Inc. in Fort Collins, Colorado, for Tolmar Therapeutics Inc.
The recall status is listed as terminated. According to the event record, this classification and the reasons given are the only facts reported in connection with this action. No additional details about patient outcomes, clinical effects, or further agency actions were included in the available data.
Class III recalls are associated with product issues that are unlikely to cause adverse health consequences, based on FDA classification criteria referenced in the record. This brief reports only the recall classification, reason, firm, and dates as stated in the FDA record. For more background on leuprolide as a compound, readers can consult the compound overview.