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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Lisdexamfetamine Dimesylate Capsules Recalled for Quality

Agency Publication Date: October 30, 2025
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Summary

Sun Pharmaceutical Industries Inc. is recalling several lots of Lisdexamfetamine Dimesylate Capsules, a prescription medication used to treat ADHD and Binge Eating Disorder. The recall was issued because the capsules failed stability testing for how quickly the medication dissolves in the body. Using a medication that does not dissolve according to specifications can affect how much of the drug is absorbed and how well the treatment works.

Risk

The capsules failed a 12-month dissolution test, meaning the medication may not release into the patient's system at the intended rate, potentially leading to ineffective treatment of symptoms.

What You Should Do

  1. If you have health concerns regarding this medication, contact your healthcare provider or pharmacist.
  2. Check your prescription bottle for the following NDC numbers: 57664-046-88, 57664-047-88, 57664-048-88, 57664-049-88, 57664-050-88, 57664-051-88, or 57664-052-88.
  3. Check the lot number and expiration date on your bottle label. Affected lots include AD42468, AD48705, AD42469, AD48707, AD42470, AD48708, AD48709, AD50894, AD48710, AD50895, AD48711, AD50896, AD48712, and AD50898. See the Affected Products section below for the full list of affected codes.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc. for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lisdexamfetamine Dimesylate Capsules (100-count bottle)
Variants: 10 mg, Capsule
Lot Numbers:
AD42468 (Exp 2/28/2026)
AD48705 (Exp 4/30/2026)
NDC:
57664-046-88

Rx only; Manufactured by OHM Laboratories

Product: Lisdexamfetamine Dimesylate Capsules (100-count bottle)
Variants: 20 mg, Capsule
Lot Numbers:
AD42469 (Exp 2/28/2026)
AD48707 (Exp 4/30/2026)
NDC:
57664-047-88

Rx only; Manufactured by OHM Laboratories

Product: Lisdexamfetamine Dimesylate Capsules (100-count bottle)
Variants: 30 mg, Capsule
Lot Numbers:
AD42470 (Exp 2/28/2026)
AD48708 (Exp 4/30/2026)
NDC:
57664-048-88

Rx only; Manufactured by OHM Laboratories

Product: Lisdexamfetamine Dimesylate Capsules (100-count bottle)
Variants: 40 mg, Capsule
Lot Numbers:
AD48709 (Exp 4/30/2026)
AD50894 (Exp 5/31/2026)
NDC:
57664-049-88

Rx only; Manufactured by OHM Laboratories

Product: Lisdexamfetamine Dimesylate Capsules (100-count bottle)
Variants: 50 mg, Capsule
Lot Numbers:
AD48710 (Exp 4/30/2026)
AD50895 (Exp 5/31/2026)
NDC:
57664-050-88

Rx only; Manufactured by OHM Laboratories

Product: Lisdexamfetamine Dimesylate Capsules (100-count bottle)
Variants: 60 mg, Capsule
Lot Numbers:
AD48711 (Exp 4/30/2026)
AD50896 (Exp 5/31/2026)
NDC:
57664-051-88

Rx only; Manufactured by OHM Laboratories

Product: Lisdexamfetamine Dimesylate Capsules (100-count bottle)
Variants: 70 mg, Capsule
Lot Numbers:
AD48712 (Exp 4/30/2026)
AD50898 (Exp 5/31/2026)
NDC:
57664-052-88

Rx only; Manufactured by OHM Laboratories

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97874
Status: Active
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Retail pharmacies
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.