Quick Facts at a Glance
- Recall Date
- August 11, 2025
- Hazard Level
- HIGH
- Brands
- Lisdexamfetamine Dimesylate, Lannett Company
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, 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
- Lisdexamfetamine Dimesylate, Lannett Company
- Product type
- Lisdexamfetamine Dimesylate Capsules 40 mg
- Model numbers
- Lot #: 25280726A, Exp. Date 03/2027
- UPC codes
- 0527-4661, 0527-4662, 0527-4663, 0527-4664, 0527-4665, 0527-4666, 0527-4667, 0527-4661-37 +6 more
- Sizes
- 100-count bottles
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 11, 2025
Reported by FDA DRUG
September 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
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
Lisdexamfetamine Dimesylate is a prescription stimulant used to treat ADHD and binge-eating disorder.
Why This Is Dangerous
Label mix-up can lead to dosing errors if patients use the mislabeled 40 mg bottle thinking it contains 40 mg when it may actually be 30 mg.
Industry Context
This recall is not described as a broader pattern for labeling errors in this product category.
Real-World Impact
Could cause under-dosing or misdosing in patients relying on the label for dosage guidance.
Practical Guidance
How to identify if yours is affected
- Check the bottle for Lot 25280726A and Exp. 03/2027.
- Verify NDC 0527-4664-37 on the label.
- Confirm actual content with prescribing information and label.
Where to find product info
NDC 0527-4664-37, Lot 25280726A, Exp. 03/2027 on packaging and bottle.
What timeline to expect
Notification by letter; replacement or guidance may take weeks.
If the manufacturer is unresponsive
- Escalate to FDA recall helpline
- Consult healthcare provider for interim dosing guidance
How to prevent similar issues
- Always verify the correct labeled strength before dispensing.
- Cross-check with pharmacy records.
- Request updated labeling from manufacturer if discrepancies arise.
Documentation advice
Keep recall letter, packaging, and any correspondence with healthcare providers.
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Product Details
Brand: Lisdexamfetamine Dimesylate. Product: Capsules, 40 mg, 100-count bottles. Distribution: Nationwide in the USA. Distributor: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-4664-37. Lot: 25280726A. Expiration: 03/2027. Quantity: 8544 bottles.
Reported Incidents
No specific injuries or adverse events are reported in the recall notice.
Key Facts
- Label mix-up between 40 mg labeled bottles and actual 30 mg content
- Recall date 2025-08-11 (FDA listing)
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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