Medications & Supplements/Prescription Drugs

Omeprazole Capsules Recalled for Foreign Medication Tablet

Agency Publication Date: July 14, 2025

Summary

Dr. Reddy's Laboratories, Inc. is recalling 1,476 bottles of Omeprazole Delayed-release Capsules (20mg). This recall was initiated after a bottle was found to contain a different medication, a Divalproex Sodium Extended-Release tablet (250mg). The affected products are 1,000-count bottles with NDC 82009-022-10 and Lot C2403017.

Risk

Taking the wrong medication can lead to serious adverse health effects. Accidental ingestion of Divalproex Sodium, which is used to treat seizures and bipolar disorder, may cause toxicity or unexpected side effects in patients who intended to take Omeprazole for stomach acid reduction.

What You Should Do

This recall affects 1,000-count bottles of Omeprazole Delayed-release Capsules (20mg) manufactured for Qualient Pharmaceuticals Health LLC with NDC 82009-022-10 and Lot C2403017 (Expiration 12/31/2026).
Identify the recalled product by checking the NDC code, lot number, and expiration date printed on the bottle label.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Dr. Reddy's Laboratories, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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: Omeprazole Delayed-release Capsules, USP (1,000-count bottle)

Variants: 20mg, Delayed-release Capsules

Lot Numbers:

C2403017 (Exp 12/31/2026)

NDC:

82009-022-10

Manufactured for Qualient Pharmaceuticals Health LLC

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97161

Status: Active

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Qualient Pharmaceuticals Health LLC

Manufactured In: India, United States

Units Affected: 1476 bottles

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 · 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.

Summary

What You Should Do

This recall affects 1,000-count bottles of Omeprazole Delayed-release Capsules (20mg) manufactured for Qualient Pharmaceuticals Health LLC with NDC 82009-022-10 and Lot C2403017 (Expiration 12/31/2026).

Identify the recalled product by checking the NDC code, lot number, and expiration date printed on the bottle label.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Dr. Reddy's Laboratories, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.