U.S. Food and Drug Administration

OCT 16, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Methylphenidate Hydrochloride (Labeling)

U.S. Food and Drug Administration

Drugs@FDA record for application ANDA209276. This is a regulatory action record, not a clinical study. Brand name: METHYLPHENIDATE HYDROCHLORIDE. Active ingredient: METHYLPHENIDATE

OCT 15, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Topiramate (Labeling)

U.S. Food and Drug Administration

Drugs@FDA record for application ANDA206210. This is a regulatory action record, not a clinical study. Brand name: TOPIRAMATE. Active ingredient: TOPIRAMATE. Sponsor: ACTAVIS LABS

OCT 15, 2026 · REGULATORY APPROVAL

FDA approval: Buprenorphine Hydrochloride

U.S. Food and Drug Administration

Drugs@FDA record for application ANDA221145. This is a regulatory action record, not a clinical study. Brand name: BUPRENORPHINE HYDROCHLORIDE. Active ingredient: BUPRENORPHINE HYD

OCT 14, 2026 · SAFETY RECALL

Class II recall: TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,

U.S. Food and Drug Administration

FDA enforcement report D-0028-2027. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: Carolina Infusion, LLC. Ini

OCT 14, 2026 · SAFETY RECALL

Class II recall: TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,

U.S. Food and Drug Administration

FDA enforcement report D-0029-2027. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: Carolina Infusion, LLC. Ini

OCT 14, 2026 · SAFETY RECALL

Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,

U.S. Food and Drug Administration

FDA enforcement report D-0023-2027. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: Carolina Infusion, LLC. Ini

OCT 14, 2026 · SAFETY RECALL

Class II recall: Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25

U.S. Food and Drug Administration

FDA enforcement report D-0012-2027. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: BioSpectra, Inc.. Initiated

OCT 14, 2026 · SAFETY RECALL

Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,

U.S. Food and Drug Administration

FDA enforcement report D-0022-2027. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: Carolina Infusion, LLC. Ini