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Class II: temporary or reversible health riskCompleted

Lannett Dextroamphetamine Saccharate Recall

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amph…

Lannett Company Inc. · Seymour, IN

Risk level
Class II
Reported by FDA
Sep 17, 2025
Recall ID
D-0642-2025
Check your lot numberHow we source this data

Summary

Lannett recalled Dextroamphetamine Saccharate starting Aug 19, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0642-2025 on Sep 17, 2025. Reason: 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. Status: Completed.

Why it was recalled

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.

Product description

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-0762-37.

Lot numbers, UPCs & expiration codes

Lot#: 25283185A. Expiry: 02/28/2027

Where it was sold

OH

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0642-2025
Classification
Class II
Status
Completed
Recall initiated
Aug 19, 2025
FDA report date
Sep 17, 2025
Quantity
4,848 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Lannett Company Inc.

Original FDA data

Every field from FDA enforcement report D-0642-2025, exactly as published.

Show all FDA fields
City
Seymour
State
IN
Status
Completed
Country
United States
Event ID
97461
Address
1101 C Ave W
Code information
Lot#: 25283185A. Expiry: 02/28/2027
Postal code
47274-3342
Report date
Sep 17, 2025
Product type
Drugs
Recall number
D-0642-2025
Classification
Class II
Recalling firm
Lannett Company Inc.
Product quantity
4,848 bottles
Reason for recall
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-0762-37.
Distribution pattern
OH
Recall initiation date
Aug 19, 2025
Initial firm notification
Letter
Center classification date
Sep 11, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0642-2025, published Sep 17, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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