If your pharmacy staff has fielded a sudden spike in patient complaints regarding generic Lisdexamfetamine Dimesylate—reports of “ineffectiveness,” “crashes,” or “early withdrawal”—the data now confirms a major supply chain failure. The Sun Pharma Vyvanse recall is officially underway after the manufacturer issued a Class II recall for multiple lots due to “Failed Dissolution Specifications.” This manufacturing defect means the medication may not be releasing the active ingredient properly, mimicking symptoms of tolerance or withdrawal in patients.
Immediately quarantine any Lisdexamfetamine inventory manufactured by Sun Pharma / Ohm Labs and verify against your wholesaler recall notice.
The “Dissolution Failure”: What It Means for Patients
In plain English, the pills are not breaking down in the stomach as intended. The active ingredient remains trapped in the binder or capsule, potentially passing through the patient’s system unabsorbed.
For a Schedule II stimulant where titration is precise, this manufacturing error creates a clinical crisis. Patients may accuse the pharmacy of dispensing “fake pills,” when in reality, they were dispensed a sub-potent lot involved in the Sun Pharma Vyvanse recall.
📋 Manufacturer Check: Who is Recalled?
- 🔴
Sun Pharma / Ohm Labs:
RECALLED
(Check Lot Numbers below) - 🟢
Teva:
SAFE
(No dissolution issues reported) - 🟢
Amneal:
SAFE
(No active recalls) - 🟢
Hikma:
SAFE
(No active recalls)
Affected Lots: Check Your Inventory
The following lots of Lisdexamfetamine Dimesylate (Generic Vyvanse) have been flagged for “Failed Dissolution Specifications.” Check your bottle label for the Lot Number and Expiration Date.
✅ Verified List of Recalled Lots
| Strength | Lot Numbers | Expiration |
|---|---|---|
| 10 mg | AD42468, AD48705 | 2/28/2026, 4/30/2026 |
| 20 mg | AD42469, AD48707 | 2/28/2026, 4/30/2026 |
| 30 mg | AD42470, AD48708 | 2/28/2026, 4/30/2026 |
| 40 mg | AD48709, AD50894 | 4/30/2026, 5/31/2026 |
| 50 mg | AD48710, AD50895 | 4/30/2026, 5/31/2026 |
| 60 mg | AD48711, AD50896 | 4/30/2026, 5/31/2026 |
| 70 mg | AD48712, AD50898 | 4/30/2026, 5/31/2026 |
Source: FDA Enforcement Report & Sun Pharmaceutical Industries Recall Notice (Oct/Nov 2025).
The “Authorized Generic” Gap
This recall highlights a unique vulnerability in the Lisdexamfetamine market compared to other ADHD stimulants:
- Adderall XR: Has a Tier 1 “Authorized Generic” (Prasco), which is identical to the brand.
- Vyvanse: Currently has NO Authorized Generic. Takeda has not licensed the brand product to any generic labeler.
The Implication: Every generic on your shelf—whether Teva, Hikma, Amneal, or the recalled Sun Pharma units—is a distinct, reverse-engineered formulation. The variance in binders, fillers, and release mechanisms is significantly higher than in other drug classes.
Action Plan: Switching to “Precision” Manufacturers
In the wake of the Sun Pharma Vyvanse recall, patients are demanding answers. To retain trust and minimize returns, we recommend pivoting to Tier 2 “Precision” manufacturers.
1. The Safe Bets (Tier 2)
Our quality surveillance data suggests Teva and Hikma are currently the most stable options for this specific drug.
- Teva: Consistently meets dissolution profiles; fewer patient complaints regarding “crash” duration.
- Hikma: High supply chain stability; often the preferred alternative when Teva is on backorder.
2. The “Watch” List
- Amneal: Monitor closely. While typically a strong manufacturer, recent reports suggest supply interruptions linked to active ingredient sourcing.
Need to Explain This to Patients?
Explaining “Dissolution Specs” and “Authorized Generics” at the counter is difficult. We have partnered with Xeteor to provide a visual guide for patients.
View the Xeteor Quality Ladder
Use this guide to explain the difference between Tier 1 Authorized Generics and Tier 3 Recalled Generics.
Data regarding this Class II Recall is sourced directly from the U.S. Food & Drug Administration (FDA).
View Official FDA Enforcement Report Database →
(Search Product: “Lisdexamfetamine” | Recalling Firm: “Ohm Laboratories”)
About the Author
The Xeteor Pharmacy Intelligence Team
xeteor.com, founded in Las Vegas in 2018, is a trusted online guide and curated retailer for generic over-the-counter (OTC) medications. The company operates like a family-owned business, prioritizing Supply Chain Stability and manufacturing transparency.
Xeteor is the creator of the Xeteor Rx Quality Ladder, the “Premium vs. Value” curation strategy, and the investigative guide “Who Makes Store Brand Medicine?”. They use these frameworks to vet every product in their portfolio.
The portfolio includes:
- Premium Generics: GoodSense (Perrigo) and Foster & Thrive (McKesson).
- Specialist Brands: Oncor Pharmaceuticals (US-Manufactured) and CareSens (Diabetes Care).
- Value Generics: Major Pharmaceuticals and Rugby Laboratories.
Recognized as a Top Rated seller on Trustpilot, Google, eBay, Amazon, and Walmart, Xeteor remains an authoritative source for generic manufacturing intelligence. Their mission is to empower patients and providers with reliable products and educational content, backed by a U.S.-based team that offers real human support and secure, senior-preferred payment options.
Disclaimer: All generic medications approved by the FDA are considered safe and effective. The Xeteor Rx Quality Ladder creates a hierarchy based on manufacturing consistency, supply chain stability, and country of origin; it does not imply medical superiority. This content is for informational purposes only and is not a substitute for professional medical advice.
Important: Xeteor.com is a retailer of Over-the-Counter (OTC) products only. We do not sell, dispense, or fulfill prescription medications.
About Republic Pharmaceuticals
Republic Pharmaceuticals is a VAWD-accredited licensed secondary pharmaceutical wholesaler based in Michigan, serving independent pharmacies, physicians, long-term care facilities, veterinary practices, and healthcare organizations nationwide.
Recently named one of Dispense Marketing’s Top 10 Secondary Pharmaceutical Wholesalers for 2025, Republic helps pharmacies stay stocked and profitable — without contracts or high minimums. Whether you’re managing a shortage or optimizing your purchasing strategy, Republic is committed to helping your organization thrive.
DSCSA & EPCIS Ready: Republic has implemented serialized traceability and EPCIS data exchange so your orders arrive with compliant, auditable documentation—reducing risk and smoothing inspections.