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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Lannett Company
- Product type
- Prescription Tablet
- Model numbers
- Lot#: 25283185A. Expiry: 02/28/2027
- UPC codes
- 0527-0760, 0527-0761, 0527-0762, 0527-0763, 0527-0764, 0527-0765, 0527-0766, 0527-0760-37 +6 more
- Sold at
- Unknown
- Where affected
- OH
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 19, 2025
Reported by FDA DRUG
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify bottle label shows Lot 25283185A and Expiry 02/28/2027.
- Confirm tablet strength is 10 mg per tablet as labeled.
- 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.
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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
- Foreign tablet in 2 bottles
- 10 mg labeled bottles contained 5 mg tablets
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Safety Guide
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