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
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
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

Timeline

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

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 1 Oct 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
ReportedClassRecallCompanyReasonWhere
DrugCLASS IILevothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg recalledAlvogenPackaging DefectsNationwide
DrugCLASS IFentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl SystemAlvogenPackaging DefectsNationwide
DrugCLASS IIBuprenorphine and Naloxone Sublingual Film 2mg/0.5mg recalled by AlvogenBuprenorphine And NaloxoneAlvogenPotency & AssayNationwide
DrugCLASS IINitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg recalledNitrofurantoin Monohydrate/ MacrocrystallineAlvogenPotency & AssayPR
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Other Levothyroxine recalls

All 145
ReportedClassRecallCompanyReasonWhere
DrugCLASS IILevothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide
DrugCLASS IILevothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide
DrugCLASS IILevothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide
DrugCLASS IILevothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide
DrugCLASS IILevothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide