HIGH

Lannett Company Recalls Dextroamphetamine Tablets Over Foreign Tablet Risk

Lannett Company recalled 4,848 bottles of Dextroamphetamine tablets on August 19, 2025. The recall stems from the presence of a foreign tablet in some bottles. This poses a significant risk to consumers who may inadvertently take the incorrect dosage.

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
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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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Product Details

The recalled product is Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, sold in bottles of 100 tablets. The lot number is 25283185A, and the expiration date is February 28, 2027.

The Hazard

The recall involves two bottles that contained one 5mg tablet instead of the intended 10mg tablet. Taking the incorrect dosage can lead to serious health risks, including overdose.

Reported Incidents

No specific injuries or incidents have been reported related to this recall. However, the potential for incorrect dosing increases the risk of adverse health effects.

What to Do

Consumers should stop using the affected product immediately. Contact Lannett Company or your healthcare provider for further guidance and to discuss possible returns.

Contact Information

For more information, consumers can reach Lannett Company at their website or through their customer service line.

Key Facts

  • Recall date: August 19, 2025
  • Reported by FDA on September 17, 2025
  • Class II recall due to high hazard level
  • Potential for overdose with incorrect dosage

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
POISONING

Product Classification

Product TypeDextroamphetamine Tablets
Sold At
Multiple Retailers

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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