Browse Drug Recalls

16 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 16 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 16 FDA drug recalls.

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DateProductReasonClassFirm
Sep 10, 2026 SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 9... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosa... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosag... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, tota... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosa... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosa... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosa... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dos... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use do... Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II Carolina Infusion, LLC
Sep 10, 2026 Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dos... Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II Carolina Infusion, LLC
Sep 10, 2026 Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use do... Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II Carolina Infusion, LLC
Sep 10, 2026 Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use do... Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II Carolina Infusion, LLC
Sep 10, 2026 TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosa... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... Class II Carolina Infusion, LLC
Sep 10, 2026 QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage... Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class II Carolina Infusion, LLC

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.