Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is LISDEXAMFETAMINE DIMESYLATE recalled?

The FDA has recorded 10 recalls of LISDEXAMFETAMINE DIMESYLATE (2024–2025) , recalled under brand like LISDEXAMFETAMINE DIMESYLATE. 9 still ongoing.

0
Class I (most serious)
10
Class II
0
Class III
9
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of LISDEXAMFETAMINE DIMESYLATE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-mo 7
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. 1
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 mon 1
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dime 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun Class II ongoing
SUN PHARMACEUTICAL INDUSTRIES INC 2025-10-28 lots: Lot #: AD48711, Expiry: 4/30/2026; AD50896, Expiry: 5/31/2026.
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun Class II ongoing
SUN PHARMACEUTICAL INDUSTRIES INC 2025-10-28 lots: Lot #:AD48710, Expiry: 4/30/2026; AD50895, Expiry: 5/31/2026.
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Bru Class II ongoing
SUN PHARMACEUTICAL INDUSTRIES INC 2025-06-16 lots: Lot # AD42648, Exp 02/28/2026
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun Class II ongoing
SUN PHARMACEUTICAL INDUSTRIES INC 2025-10-28 lots: Lot #: AD48712, Expiry: 4/30/2026; AD50898, Expiry: 5/31/2026.
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadel Class II Completed
Lannett Company Inc. 2025-08-11 lots: Lot #: 25280726A, Exp. Date 03/2027
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun Class II ongoing
SUN PHARMACEUTICAL INDUSTRIES INC 2025-10-28 lots: Lot #: AD42469, Expiry: 2/28/2026; AD48707, Expiry:4/30/2026.
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun Class II ongoing
SUN PHARMACEUTICAL INDUSTRIES INC 2025-10-28 lots: Lot #: AD42468, Expiry: 2/28/2026; AD48705, Expiry: 4/30/2026.
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun Class II ongoing
SUN PHARMACEUTICAL INDUSTRIES INC 2025-10-28 lots: Lot #: AD48709, Expiry: 4/30/2026; AD50894, Expiry: 5/31/2026.
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun Class II ongoing
SUN PHARMACEUTICAL INDUSTRIES INC 2025-10-28 lots: Lot #: AD42470, Expiry: 2/28/2026; AD48708, Expiry:4/30/2026.
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelp Class II Terminated
Lannett Company Inc. 2024-10-25 lots: Lot: 23274856A, Exp 04/30/2025

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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