FDA drug recalls · openFDA
Is LEVOTHYROXINE SODIUM recalled?
The FDA has recorded 54 recalls of LEVOTHYROXINE SODIUM (2023–2026) , recalled under brands like LEVOTHYROXINE SODIUM, LEVOXYL, SYNTHROID. 37 still ongoing.
0
Class I (most serious)
52
Class II
2
Class III
37
ongoing
A recall doesn't mean your pills are affected
Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of LEVOTHYROXINE SODIUM ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.
Why it was recalled
Subpotent Drug 16
Superpotent Drug and Subpotent Drug: potency failures obtained 11
Subpotent Drug: Assay below the approved specification 7
Subpotent and Superpotent Drug 6
Subpotent 4
The recalls
Class I and ongoing recalls first. Tap a recall for its full record and lot detail.
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Pri Class II ongoing
MACLEODS PHARMA USA, INC 2026-02-26 lots: Lot 16240062A, exp date 3/2026
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R Class II ongoing
ACCORD HEALTHCARE, INC. 2025-04-10 lots: Lot # D2300044, Exp Date: 12/2025
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I Class II ongoing
ACCORD HEALTHCARE, INC. 2025-06-20 lots: Lot #D2300076, Exp Date: 12/31/2025
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc Class II ongoing
ACCORD HEALTHCARE, INC. 2025-06-20 lots: Lot #D2300325, Exp Date: 01/31/2026; Lot #D2400536, Exp Date: 02/28/2026
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablet Class II ongoing
Mylan Institutional, Inc. 2025-03-07 lots: Lot 3115773, Exp. 03/31/2025
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc. Class II ongoing
ACCORD HEALTHCARE, INC. 2025-06-20 lots: Lot #D2300087, Exp Date: 12/31/2025
Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, N Class II ongoing
Pfizer 2025-07-29 lots: Lot #: 24C11, Exp 2/28/2026.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Ra Class II ongoing
ACCORD HEALTHCARE, INC. 2025-04-10 lots: Lot # D2400725, Exp Date: 03/2026
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Class II ongoing
ACCORD HEALTHCARE, INC. 2025-06-20 lots: Lot #D2300042, Exp Date: 12/31/2025
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Class II ongoing
ACCORD HEALTHCARE, INC. 2025-06-20 lots: Lot #D2300104, Exp Date: 12/31/2025
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, Class II ongoing
Alvogen, Inc 2025-12-31 lots: Lot # MHA21825, Exp Date: December 31, 2027
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I Class II ongoing
ACCORD HEALTHCARE, INC. 2025-06-20 lots: Lot #D2400679, Exp Date: 02/28/2026
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Ra Class II ongoing
ACCORD HEALTHCARE, INC. 2025-04-10 lots: Lot # D2400547, Exp Date: 02/2026
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets Class II ongoing
Mylan Institutional, Inc. 2025-03-07 lots: Lot 3116074, Exp. 09/30/2025
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare Class II ongoing
ACCORD HEALTHCARE, INC. 2025-09-16 lots: Lot # D2300045, Exp 12/31/2025.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R Class II ongoing
ACCORD HEALTHCARE, INC. 2025-04-10 lots: Lot # D2300323, Exp Date: 01/2026
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, In Class II ongoing
ACCORD HEALTHCARE, INC. 2025-06-20 lots: Lot #D2300092, Exp Date: 12/31/2025; Lot #D2400722, Exp Date: 03/31/2026
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles Class II ongoing
Viatris Inc 2024-11-18 lots: Lot #: a) 8177720, Exp. Date Jun 2025; b) 3200218, Exp. Date Jun 2025
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles Class II ongoing
Viatris Inc 2024-11-18 lots: Lot #: a) 8171269, Exp. Date Feb 2025; 8179579, Exp. Date July 2025 b)3183815, Exp. Date Nov 2024; 3189147, Exp. Date Jan 2025; 3192027, Exp. Date Feb 2025; 3202894, Exp. Date Jul 2025; 3192026, Exp. Date Feb 2025; 3199781, Exp. Date Jun 2025. 3192028, exp. date Feb 2025 3202895, exp. date July 2025
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets Class II ongoing
Mylan Institutional, Inc. 2024-11-19 lots: Lot #: 3115893, Exp. Date 6/2025
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets Class II ongoing
Mylan Institutional, Inc. 2024-11-19 lots: Lot #: 3115869, Exp. Date 03/2025
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles ( Class II ongoing
Viatris Inc 2024-11-18 lots: Lot #: a) 8174701, Exp. Date April 2025; 8182228, Exp. Date Aug 2025 b)3193984, Exp. Date Mar 2025; 3206790, Exp. Date Aug 2025
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets ea Class II ongoing
Mylan Institutional, Inc. 2024-11-19 lots: Lot #: 3115936, Exp. Date 07/2025
Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets Class II ongoing
Mylan Institutional, Inc. 2024-11-19 lots: Lot #: 3115924, Exp. Date 06/2025
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I Class II ongoing
ACCORD HEALTHCARE, INC. 2024-11-08 lots: Lot #: D2300191, Exp 12/31/2025
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets Class II ongoing
Mylan Institutional, Inc. 2024-11-19 lots: Lot #: 3115707, Exp. Date 02/2025
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles Class II ongoing
Viatris Inc 2024-11-18 lots: Lot #: a) 3182797, Exp. Date Nov 2024; 8177587, b) 3199816, Exp. Date Jun 2025
Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles Class II ongoing
Viatris Inc 2024-11-18 lots: Lot #: a)8179847, Exp. Date July 2025; b) 3203518, Exp. Date July 2025
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets Class II ongoing
Mylan Institutional, Inc. 2024-11-19 lots: Lot #: 3115448, Exp. Date 12/31/2024;3115732, Exp. Date 3/31/2025; 3116024, Exp. Date 9/30/2025
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, I Class II Terminated
Lupin Pharmaceuticals Inc. 2024-12-20 lots: Lot# LA01276, Exp Date: 07/2026
Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles Class II ongoing
Viatris Inc 2024-11-18 lots: Lot #: a) 8171623, Exp. Date Feb 2025; 8164486, Exp. Date Nov 2024 b)3205462, Exp. Date Aug 2025; 3192428, Exp. Date Feb 2025; 3184096, Exp. Date Nov 2024
Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles Class II ongoing
Viatris Inc 2024-11-18 lots: Lot #: a) 3192915, 8172108, Exp. Date Mar 2025; b) 3208680, Exp. Date Sep 2025
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles Class II ongoing
Viatris Inc 2024-11-18 lots: Lot #: a) 8165919, Exp. Date Dec 2024; 8172050, Exp. Date Mar 2025; 8183251, Exp. Date Sept 2025 b) 3185542, Exp. date Dec 2024; 3192838, Exp. Date Mar 2025; 3208172, Exp. Date Sept 2025
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles ( Class II ongoing
Viatris Inc 2024-11-18 lots: Lot # a) 8180781, Exp. Date Aug 2025; b)3191628, Exp. Date Feb 2025; 3197139, Exp. Date Apr 2025; 3188976, Exp. Date Jan 2025; 3184929, Exp. Date Dec 2024; 3204909, Exp. Date Aug 2025
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles ( Class II ongoing
Viatris Inc 2024-11-18 lots: Lot #: a) 8177078, Exp. Date May 2025; 8168596, Exp. Date Jan 2025 b) 3199313, Exp. Date May 2025; 3194118, Exp. Date Mar 2025; 3186238, Exp. Date Dec 2024; 3209590, Exp. Date Sep 2025; 3199317, Exp. Date May 2025; 3188733, Exp. Date Jan 2025
Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles ( Class II ongoing
Viatris Inc 2024-11-18 lots: Lot #: a) 8181875, Exp. Date Aug 2025; 8174497, Exp. Date April 2025 b) 3209099, Exp. Date Sep 2025; 3206534, Exp. Date Aug 2025; 3196137, Exp. Date April 2025
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 5 Class II Terminated
Alvogen, Inc 2023-02-06 lots: Lot # HE02221, Exp. 05/2023
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220418, Exp. 10/2023; 220560, Exp. 11/2023.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220415, Exp. 10/2023; 221052, Exp. 04/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220853, Exp. 02/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220959, Exp. 3/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220556, Exp. 11/2023; 221058, Exp. 04/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220416, Exp. 10/2023; 221053, Exp. 4/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220414, Exp. 10/2023; 220852, Exp. 02/2024; 220970, Exp. 03/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220552, Exp. 11/2023; 221055, Exp. 04/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220855, Exp. 2/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220411, Exp. 10/2023; 220854, Exp. 02/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220413, Exp. 10/2023; 220964, Exp. 3/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220409, Exp. 10/2023; 220956, Exp. 03/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220553, Exp. 11/2023; 221056, Exp. 04/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220407, Exp. 10/2023; 220960, Exp. 03/2024.
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I Class II Terminated
IBSA PHARMA INC 2023-01-30 lots: Lot #: 220856, Exp. 2/2024.
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Class III ongoing
Macleods Pharmaceuticals Ltd 2025-05-29 lots: Lot #: MLF2401A, Exp 01/31/2026
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 6 Class III ongoing
AbbVie Inc. 2023-10-17 lots: Lot # 1187435 exp date: 02/2024
RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.