NDC 16729-453

Levothyroxine sodium 125 ug tablet

On the label: Accord Healthcare Inc..

Where it's made

Excella GmbH & Co. KG

Feucht, Germany · makes the active ingredient

Problems found, fixed voluntarily Last FDA inspection Oct 19, 2022. 7 inspections on record.

Intas Pharmaceuticals Limited

Dehradun, India · makes it and tests it

Serious problems, FDA action Last FDA inspection Sep 16, 2025. 1 inspection on record, 1 with serious problems.

Recalls

• Aug 6, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: Lot #: D2401927, D2401833, Exp. Date 08/31/2026; D2402551, D2402552, Exp. Date 11/30/2026; D2500220, Exp. Date 12/31/2026; D2500223, Exp. Date 01/31/2027.
• Aug 6, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: Lot #: D2401834, D2401982, Exp. Date 08/31/2026; D2402584, D2402585, D2402586, D2402588, D2402587, D2402589, Exp Date. 11/30/2026.
• Aug 6, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: Lot #: D2402016, D2402017, Exp. Date 08/31/2026
• Aug 6, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: Lot #: D2401813, D2401814, Exp. Date 08/31/2026; D2500200, D2500219, Exp. Date 12/31/2026.
• Aug 6, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: a) Lot #: D2402186, Exp. Date 09/30/2026. b) Lot #: D2402019, Exp. Date 08/31/2026; D2402094, Exp. Date 09/30/2026; D2500022, D2500023, D2500021, Exp. Date 12/31/2026.
• Aug 6, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: Lot #: D2402443, D2402444, D2402445, Exp. Date 10/31/2026.
• Aug 6, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: Lot #: D2401983, Exp. Date 08/31/2026; D2402640, D2402641, Exp. Date 11/30/2026; D2500224, Exp. Date 01/31/2027.
• Aug 6, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: a) Lot # D2402125, D2402126, D2402127, Exp. Date 09/30/2026. b) Lot #: D2402523, D2402524, Exp. Date 11/30/2026.
• Aug 6, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: Lot #: D2402195, D2402196, D2402197, Exp. Date 09/30/2026.
• Aug 6, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: a) Lot #: D2402642, Exp. Date 11/30/2026 b) Lot #: D2401832, Exp. Date 08/31/2026; D2402525, D2402527, D2402526, D2402644, D2402643, Exp. Date 11/30/2026.
• Aug 6, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: a) Lot # D2402430, D2402431, Exp Date: 10/31/2026. b) Lot #: D2402432, Exp. Date 10/31/2026; D2500180, Exp. Date 12/31/2026.
• Aug 6, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: Lot #: D2402337, Exp. Date 10/31/2026.
• Jun 8, 2026 · Class II · Ongoing
  Subpotent Drug
  Lots: Lot # D2401522, Exp Date: 06/2026.
• Sep 16, 2025 · Class II · Ongoing
  Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
  Lots: Lot # D2300045, Exp 12/31/2025.
• Jun 20, 2025 · Class II · Ongoing
  Subpotent Drug: Assay below the approved specification
  Lots: Lot #D2300325, Exp Date: 01/31/2026; Lot #D2400536, Exp Date: 02/28/2026
• Jun 20, 2025 · Class II · Ongoing
  Subpotent Drug: Assay below the approved specification
  Lots: Lot #D2400679, Exp Date: 02/28/2026
• Jun 20, 2025 · Class II · Ongoing
  Subpotent Drug: Assay below the approved specification
  Lots: Lot #D2300087, Exp Date: 12/31/2025
• Jun 20, 2025 · Class II · Ongoing
  Subpotent Drug: Assay below the approved specification
  Lots: Lot #D2300092, Exp Date: 12/31/2025; Lot #D2400722, Exp Date: 03/31/2026
• Jun 20, 2025 · Class II · Ongoing
  Subpotent Drug: Assay below the approved specification
  Lots: Lot #D2300104, Exp Date: 12/31/2025
• Jun 20, 2025 · Class II · Ongoing
  Subpotent Drug: Assay below the approved specification
  Lots: Lot #D2300076, Exp Date: 12/31/2025
• Jun 20, 2025 · Class II · Ongoing
  Subpotent Drug: Assay below the approved specification
  Lots: Lot #D2300042, Exp Date: 12/31/2025
• Apr 10, 2025 · Class II · Ongoing
  Subpotent
  Lots: Lot # D2300323, Exp Date: 01/2026
• Apr 10, 2025 · Class II · Ongoing
  Subpotent
  Lots: Lot # D2400547, Exp Date: 02/2026
• Apr 10, 2025 · Class II · Ongoing
  Subpotent
  Lots: Lot # D2300044, Exp Date: 12/2025
• Apr 10, 2025 · Class II · Ongoing
  Subpotent
  Lots: Lot # D2400725, Exp Date: 03/2026
• Nov 8, 2024 · Class II · Terminated
  Subpotent drug
  Lots: Lot #: D2300191, Exp 12/31/2025

Product details

Generic drug

Levothyroxine: see every company that makes it

Form

tablet, oral

Strength

125 ug

Approval

ANDA ANDA212399

On the market since

Dec 3, 2020

Package NDCs

16729-453-15 16729-453-17

Official label

DailyMed (National Library of Medicine), updated Oct 17, 2025

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