Omeprazole capsules recalled due to foreign medication contamination
Dr. Reddy's Laboratories is recalling Omeprazole 20mg capsules due to the presence of foreign Divalproex Sodium 250mg tablets in bottles. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with risk of harm from ingesting an unintended medication, but no reported illnesses or injuries. The contamination creates potential for serious adverse effects, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Omeprazole Delayed-release Capsules, USP, 20mg (NDC 82009-022-10). Bottles with lot number C2403017, expiration date 12/31/2026, have been found to contain foreign Divalproex Sodium Extended-Release 250mg tablets. Approximately 1,476 bottles were distributed nationwide.
The issue involves the presence of Divalproex Sodium tablets—a medication used to treat seizure disorders and bipolar disorder—in bottles of Omeprazole capsules. Divalproex Sodium is a different medication with different indications and potential side effects. Taking this medication unintentionally could cause serious harm, especially for patients who depend on Omeprazole or who have contraindications to Divalproex Sodium.
No illnesses or adverse events have been reported. Patients with the affected lot number should stop using the product and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- OMEPRAZOLE (OMEPRAZOLE)
- Brand
- OMEPRAZOLE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug
- Hazard
- foreign-medication
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: C2403017
- Exp 12/31/2026
Distribution
Distributed nationwide across the United States.
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