HIGH

Lannett 10mg Dextroamphetamine Tablets Recalled for Foreign Tablet Contamination (2025)

Lannett Company Inc. recalls 4,848 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. A bottle labeled 10 mg 100-count contained a 5 mg tablet. Two bottles were affected. Consumers and healthcare providers should stop using this product immediately. Contact Lannett or a healthcare provider for guidance.

Quick Facts at a Glance

Recall Date
August 19, 2025
Hazard Level
HIGH
Brands
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Lannett Company
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
PREGNANT, GENERAL, PETS

Hazard Information

Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.

What You Should Do

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

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About This Product

Dextroamphetamine tablets are prescription stimulants used to treat ADHD and narcolepsy. Medical supervision is required.

Why This Is Dangerous

A 10 mg bottle containing a 5 mg tablet alters prescribed dosage, risking under or overdosing depending on the patient's regimen.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Immediate action required; patients must stop use and consult a clinician to adjust therapy.

Practical Guidance

How to identify if yours is affected

  1. Verify bottle label shows Lot 25283185A and Expiry 02/28/2027.
  2. Confirm tablet strength is 10 mg per tablet as labeled.
  3. Check for any bottle labeled 10 mg, 100-count containing 5 mg tablets.

Where to find product info

FDA recall page and Lannett customer service for guidance.

What timeline to expect

Refund or replacement processing timelines vary; follow company instructions.

If the manufacturer is unresponsive

  • Document all contact attempts.
  • Contact FDA CFSAN recall contacts if the company is unresponsive.

How to prevent similar issues

  • Verify packaging integrity upon receipt.
  • Consult prescriber before using any dosage changes.
  • Keep medication in original packaging with lot numbers visible.

Documentation advice

Save recall notice, packaging, lot number, and any adverse event records.

Product Details

Brand: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate. Distributor: Lannett Company, Inc. Location: Philadelphia, PA 19136. NDC: 0527-0762-37. Quantity recalled: 4,848 bottles. Sold in OH. Classification: Class II. Expiry: 02/28/2027. Lot #: 25283185A.

Reported Incidents

No specific injuries or incidents are described in the recall notice. Information shows presence of foreign tablet in two bottles.

Key Facts

  • 4,848 bottles recalled
  • Lot 25283185A
  • Expiry 02/28/2027
  • OH distribution
  • Foreign tablet in 2 bottles
  • 10 mg labeled bottles contained 5 mg tablets

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
PREGNANTGENERALPETS
Injury Types
POISONINGELECTRICAL

Product Details

Model Numbers
Lot#: 25283185A. Expiry: 02/28/2027
UPC Codes
0527-0760
0527-0761
0527-0762
+11 more
Affected States
OH
Report Date
September 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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