NDC 72189-346
Levothyroxine Sodium 200 ug tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Accord Healthcare Inc.'s NDC 16729-457.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Excella GmbH & Co. KG | Feucht, Germany | Makes the active ingredient | Problems found, fixed voluntarilyOct 19, 2022 · 7 inspections |
| Intas Pharmaceuticals Limited | Dehradun, India | Makes it and tests it | Serious problems, FDA actionSep 16, 2025 · 1 inspection, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Aug 6, 2026 · Class II · Accord Healthcare, Inc.
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 · Accord Healthcare, Inc.
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 · Accord Healthcare, Inc.
Subpotent Drug
Lots: Lot #: D2402016, D2402017, Exp. Date 08/31/2026 - Aug 6, 2026 · Class II · Accord Healthcare, Inc.
Subpotent Drug
Lots: Lot #: D2401813, D2401814, Exp. Date 08/31/2026; D2500200, D2500219, Exp. Date 12/31/2026. - Aug 6, 2026 · Class II · Accord Healthcare, Inc.
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 · Accord Healthcare, Inc.
Subpotent Drug
Lots: Lot #: D2402443, D2402444, D2402445, Exp. Date 10/31/2026. - Aug 6, 2026 · Class II · Accord Healthcare, Inc.
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 · Accord Healthcare, Inc.
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 · Accord Healthcare, Inc.
Subpotent Drug
Lots: Lot #: D2402195, D2402196, D2402197, Exp. Date 09/30/2026. - Aug 6, 2026 · Class II · Accord Healthcare, Inc.
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 · Accord Healthcare, Inc.
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 · Accord Healthcare, Inc.
Subpotent Drug
Lots: Lot #: D2402337, Exp. Date 10/31/2026. - Jun 8, 2026 · Class II · Accord Healthcare, Inc.
Subpotent Drug
Lots: Lot # D2401522, Exp Date: 06/2026. - Sep 16, 2025 · Class II · Accord Healthcare, Inc.
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 · Accord Healthcare, Inc.
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 · Accord Healthcare, Inc.
Subpotent Drug: Assay below the approved specification
Lots: Lot #D2400679, Exp Date: 02/28/2026 - Jun 20, 2025 · Class II · Accord Healthcare, Inc.
Subpotent Drug: Assay below the approved specification
Lots: Lot #D2300087, Exp Date: 12/31/2025 - Jun 20, 2025 · Class II · Accord Healthcare, Inc.
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 · Accord Healthcare, Inc.
Subpotent Drug: Assay below the approved specification
Lots: Lot #D2300104, Exp Date: 12/31/2025 - Jun 20, 2025 · Class II · Accord Healthcare, Inc.
Subpotent Drug: Assay below the approved specification
Lots: Lot #D2300076, Exp Date: 12/31/2025 - Jun 20, 2025 · Class II · Accord Healthcare, Inc.
Subpotent Drug: Assay below the approved specification
Lots: Lot #D2300042, Exp Date: 12/31/2025 - Apr 10, 2025 · Class II · Accord Healthcare, Inc.
Subpotent
Lots: Lot # D2300323, Exp Date: 01/2026 - Apr 10, 2025 · Class II · Accord Healthcare, Inc.
Subpotent
Lots: Lot # D2400547, Exp Date: 02/2026 - Apr 10, 2025 · Class II · Accord Healthcare, Inc.
Subpotent
Lots: Lot # D2300044, Exp Date: 12/2025 - Apr 10, 2025 · Class II · Accord Healthcare, Inc.
Subpotent
Lots: Lot # D2400725, Exp Date: 03/2026 - Nov 8, 2024 · Class II · Accord Healthcare, Inc.
Subpotent drug
Lots: Lot #: D2300191, Exp 12/31/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Levothyroxine: every company that makes it
- Form
- tablet, oral
- Strength
- 200 ug
- Approval
- ANDA ANDA212399
- On the market since
- Apr 19, 2022
- Package NDCs
72189-346-90- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2025
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