Lisdexamfetamine Dimesylate Capsules recall
FDA recall D-0149-2026 · initiated Oct 28, 2025
SUN PHARMACEUTICAL INDUSTRIES INC recalled Lisdexamfetamine Dimesylate Capsules in Oct 2025 — an FDA Class II recall (D-0149-2026) because Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- Product
- Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-051-88.
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S Nationwide.
- Initiated
- Oct 28, 2025
- FDA report date
- Nov 5, 2025
Frequently asked
- Was Lisdexamfetamine Dimesylate Capsules recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Lisdexamfetamine Dimesylate Capsules in Oct 2025 — an FDA Class II recall (D-0149-2026) because Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lisdexamfetamine Dimesylate Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0149-2026 was: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- Is a recalled Lisdexamfetamine Dimesylate Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lisdexamfetamine Dimesylate Capsules are affected?
- Distributed: U.S Nationwide.. The recall covers these lots — Lot #: AD48711, Expiry: 4/30/2026; AD50896, Expiry: 5/31/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0149-2026.