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Recall Enforment Report D-0524-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by ACCORD HEALTHCARE, INC., originally initiated on 06-20-2025 for the product Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17 The product was recalled due to subpotent drug: assay below the approved specification. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0524-202506-20-202507-23-2025Class II2,344 bottlesLevothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17Subpotent Drug: Assay below the approved specificationOngoing
D-0519-202506-20-202507-23-2025Class II2,352 bottlesLevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17Subpotent Drug: Assay below the approved specificationOngoing
D-0521-202506-20-202507-23-2025Class II9,739 bottlesLevothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17Subpotent Drug: Assay below the approved specificationOngoing
D-0520-202506-20-202507-23-2025Class II54,227 bottlesLevothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-15Subpotent Drug: Assay below the approved specificationOngoing
D-0523-202506-20-202507-23-2025Class II4,921 bottlesLevothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17Subpotent Drug: Assay below the approved specificationOngoing
D-0518-202506-20-202507-23-2025Class II82,159 bottlesLevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15Subpotent Drug: Assay below the approved specificationOngoing
D-0522-202506-20-202507-23-2025Class II4,896 bottlesLevothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17Subpotent Drug: Assay below the approved specificationOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
16729-447Levothyroxine Sodium Levothyroxine SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-448Levothyroxine Sodium Levothyroxine SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-449Levothyroxine Sodium Levothyroxine SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-450Levothyroxine Sodium Levothyroxine SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-451Levothyroxine Sodium Levothyroxine SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-452Levothyroxine Sodium Levothyroxine SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-453Levothyroxine Sodium Levothyroxine SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-454Levothyroxine Sodium Levothyroxine SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-455Levothyroxine Sodium Levothyroxine SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-456Levothyroxine Sodium Levothyroxine SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-457Levothyroxine Sodium Levothyroxine SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-458Levothyroxine Sodium Levothyroxine SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug