The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1057-2026·Announced 2026-01-21

Levothyroxine tablets recalled after a bottle held the wrong strength

Alvogen is recalling a lot of Levothyroxine Sodium Tablets, 150mcg, after a pharmacy reported a single bottle containing 88 mcg tablets instead of 150 mcg tablets.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: a bottle containing a different tablet strength than labelled can lead to a patient taking the wrong dose, and no injuries are reported.

Plain-English summary

Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, in 1000-tablet bottles, manufactured by LLOYD, Inc. of Shenandoah, Iowa and distributed by Alvogen, Inc. of Pine Brook, New Jersey, under NDC 47781-662-10, are being recalled.

The reason given in the enforcement record is a product mix-up: a single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.

The recall covers lot MHA21825, expiry December 31, 2027. The record does not state a quantity. Distribution was nationwide in the US. The FDA has classified the action as Class II.

A bottle holding a different strength than the label states can result in a patient taking the wrong dose. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.

The recalled product

Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5)…
Manufacturer
Medline Industries, LP
Category
Drug — Thyroid hormone
Hazard
Affected units
11,173

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Medline kit SKU DYKS1378B
  • UDI/DI 10195327521660 (EA) 40195327521661 (CS)
  • Lot Number 25HBB410
  • Medline kit SKU DYKS1448B
  • UDI/DI 10195327691349 (EA) 40195327691340 (CS)
  • Lot Number 25HBE055
  • Medline kit SKU DYKS1163G
  • UDI/DI 10195327503185 (EA) 40195327503186 (CS)
  • Lot Number 25HBF057
  • Medline kit SKU DYKS1487I
  • UDI/DI 10198459415678 (EA) 40198459415679 (CS)
  • Lot Number 25HBI512
  • Medline kit SKU DYKS2056A
  • UDI/DI 10198459467493 (EA) 40198459467494 (CS)
  • Lot Number 25HBK906
  • Medline kit SKU DYKS2074
  • UDI/DI 10198459399893 (EA) 40198459399894 (CS)
  • Lot Number 25HBV987
  • Medline kit SKU DYKS2083
  • UDI/DI 10198459435126 (EA) 40198459435127 (CS)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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