HIGHFDA DRUG

Pfizer Levoxyl Recall: Subpotent Levoxyl 50 mcg Tablets, 29,004 Bottles in U.S. Market (2025)

Pfizer's Levoxyl 50 mcg levothyroxine tablets are recalled due to subpotency. About 29,004 bottles distributed in the U.S. since distribution. Consumers should stop use and contact their healthcare provider for guidance.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
July 29, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
July 29, 2025
Hazard Level
HIGH
Brands
Levoxyl, Pfizer Laboratories Div Pfizer Inc
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL, PREGNANT, ELDERLY

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Levoxyl, Pfizer Laboratories Div Pfizer Inc
Product type
Levothyroxine (Levoxyl) tablets
Model numbers
Lot #: 24C11, Exp 2/28/2026
UPC codes
60793-850, 60793-851, 60793-852, 60793-853, 60793-854, 60793-855, 60793-856, 60793-857 +12 more
Sizes
100-count bottle
Sold at
Multiple Retailers

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    July 29, 2025

  2. Reported by FDA DRUG

    August 20, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Subpotent drug

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Pfizer or your healthcare provider for guidance. Notification method: Letter

About This Product

Levoxyl is a brand of levothyroxine used to replace or supplement thyroid hormone. Patients depend on consistent dosing to manage hypothyroidism.

Why This Is Dangerous

Subpotent medication may not provide adequate thyroid hormone, reducing treatment efficacy and symptom control.

Industry Context

This recall is not part of a broader pattern of levothyroxine potency issues reported in recent months.

Real-World Impact

High if subpotent therapy leads to under-treatment of hypothyroidism; patients may need monitoring and dose adjustments.

Practical Guidance

How to identify if yours is affected

  1. Check NDC 60793-851-01 on your medication bottle.
  2. Look for Lot 24C11 and Exp 02/28/2026.
  3. Confirm 100-count Rx bottle and labeling 'Levoxyl'.

Where to find product info

On the bottle label, package insert, and Pfizer recall notices linked to FDA enforcement page.

What timeline to expect

Refunds or replacements depend on Pfizer notification and provider guidance; typically weeks to months.

If the manufacturer is unresponsive

  • Document all communications with your pharmacy or prescriber.
  • Escalate to Pfizer recalls hotline or FDA if no response.

How to prevent similar issues

  • Verify potency if switching manufacturers or lots.
  • Coordinate dose changes with a clinician during substitutions.
  • Monitor thyroid levels when changing brands or lots.

Documentation advice

Keep bottle, packaging, receipt, and recall notices for records.

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Product Details

Brand: Levoxyl. Product: Levothyroxine sodium tablets, USP, 50 mcg. Bottle: 100-count. NDC: 60793-851-01. Distributed by Pfizer Inc., New York, NY 10017. Made in Austria. Lot: 24C11. Expiration: 02/28/2026. Quantity: 29,004 bottles. Sold as Rx-only. Distribution: Within the U.S.

Reported Incidents

No injuries or incidents have been reported in the recall notice.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTELDERLYPETSPREGNANT
Injury Types
OTHER

Product Details

Model Numbers
Lot #: 24C11
Exp 2/28/2026
UPC Codes
60793-850
60793-851
60793-852
+17 more
Report Date
August 20, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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