CLASS II ONGOING Drug recall · Reported 5 Nov 2025 · FDA Enforcement Report
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII recalled
SUN Pharmaceutical Industries is recalling Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, distributed nationwide in the US. The recall was initiated on 28 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0146-2026
- FDA event ID
- 97874
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Oct 2025
- FDA classified
- 30 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 28 Oct 2025 | Recall initiated by company | |
| 30 Oct 2025 | Classified by FDA | +2 days |
| 5 Nov 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Lisdexamfetamine Dimesylate Capsules, 30 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 57664-048-88.
Where it was distributed
U.S Nationwide.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: AD42470, Expiry: 2/28/2026; AD48708, Expiry:4/30/2026.
Where was it sold?
U.S Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 97874This product is part of a recall event; the main page for the event is Lisdexamfetamine Dimesylate Capsules, 60 mg, CII recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lisdexamfetamine Dimesylate Capsules, 60 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide | |
| CLASS II | Lisdexamfetamine Dimesylate Capsules, 50 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide | |
| CLASS II | Lisdexamfetamine Dimesylate Capsules, 70 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide | |
| CLASS II | Lisdexamfetamine Dimesylate Capsules, 20 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide | |
| CLASS II | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide | |
| CLASS II | Lisdexamfetamine Dimesylate Capsules, 40 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
More recalls from SUN Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Lisdexamfetamine Dimesylate recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 40 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 20 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 70 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 50 mg, CII recalledLisdexamfetamine Dimesylate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |