CLASS II Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report

Levothyroxine Sodium Tablets, USP 112 mcg recalled by Alvogen

Alvogen is recalling Levothyroxine Sodium Tablets, USP 112 mcg per, distributed nationwide in the US. The recall was initiated on 6 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # HE02221, Exp. 05/2023

NDC47781-640, 47781-643, 47781-646, 47781-649, 47781-651, 47781-654

UPC0347781649906, 0347781671907, 0347781643904, 0347781657901, 0347781640903, 0347781651909

Quantity recalled21,276 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0353-2023
FDA event ID: 91654
Recalling firm: Alvogen, Morristown, NJ
Brand: Levothyroxine Sodium
Manufacturer: Alvogen, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 6 Feb 2023
FDA classified: 24 Feb 2023
Reported: 8 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Thyroid Medication

Timeline

6 Feb 2023	Recall initiated by company
24 Feb 2023	Classified by FDA	+18 days
8 Mar 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sub-Potent Drug: Out of specification for assay at the 24 month interval.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.

Where it was distributed

Nationwide and Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Is Levothyroxine Sodium Tablets, USP 112 mcg per recalled?

Yes. Alvogen recalled Levothyroxine Sodium Tablets, USP 112 mcg per on 6 Feb 2023. The recall is Class II and its status is Terminated. Recall number D-0353-2023.

Why was it recalled?

Sub-Potent Drug: Out of specification for assay at the 24 month interval.

Which lots are affected?

Lot # HE02221, Exp. 05/2023

Where was it sold?

Nationwide and Puerto Rico.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Alvogen

All 21

Reported	Class	Recall	Company	Reason	Where
21 Jan 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg recalledLevothyroxine Sodium	Alvogen	Packaging Defects	Nationwide
26 Feb 2025Drug	CLASS I	Fentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl System	Alvogen	Packaging Defects	Nationwide
14 Jul 2021Drug	CLASS II	Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg recalled by AlvogenBuprenorphine And Naloxone	Alvogen	Potency & Assay	Nationwide
21 Aug 2019Drug	CLASS II	Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg recalledNitrofurantoin Monohydrate/ Macrocrystalline	Alvogen	Potency & Assay	PR
21 Aug 2019Drug	CLASS II	Macrobid Urinary Tract Anitbacterial, 100 mg recalled by AlvogenMacrobid	Alvogen	Potency & Assay	PR

Other Levothyroxine recalls

All 114

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 112 mcg 112 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 88 mcg 088 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 100 mcg 1 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 175 mcg 175 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 150 mcg 15 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide