Lisdexamfetamine Dimesylate Capsules recall
FDA recall D-0516-2025 · initiated Jun 16, 2025
SUN PHARMACEUTICAL INDUSTRIES INC recalled Lisdexamfetamine Dimesylate Capsules in Jun 2025 — an FDA Class II recall (D-0516-2025) because Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
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 9 month long term stability station (25¿C, 60%RH).
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: 5,448 bottles
Details
- Product
- Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
- Initiated
- Jun 16, 2025
- FDA report date
- Jul 23, 2025
Frequently asked
- Was Lisdexamfetamine Dimesylate Capsules recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Lisdexamfetamine Dimesylate Capsules in Jun 2025 — an FDA Class II recall (D-0516-2025) because Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH). 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-0516-2025 was: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
- 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: Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.. The recall covers these lots — Lot # AD42648, Exp 02/28/2026. 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-0516-2025.