Omeprazole capsule bottle contained a foreign divalproex sodium tablet
Omeprazole Delayed-release Capsules USP 20 mg are being recalled because a foreign Divalproex Sodium Extended-Release 250 mg tablet was found in a bottle. 1,476 bottles affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Risk-of-harm product: a wrong drug found inside a bottle means a patient could take a medicine that was never prescribed, with no injury reported in the source.
Plain-English summary
Omeprazole Delayed-release Capsules, USP, 20 mg, 1000-count bottles, prescription only, manufactured by Dr. Reddy's Laboratories Limited of India for Qualient Pharmaceuticals Health LLC, are being recalled. The action covers 1,476 bottles.
The stated reason is the presence of foreign tablets or capsules: a foreign Divalproex Sodium Extended-Release 250 mg tablet was present in a bottle of omeprazole capsules. The FDA classified the action as Class II.
The affected lot is C2403017, expiring 12/31/2026. Distribution was nationwide in the USA.
Patients and pharmacies holding the affected lot should check the contents and speak to a pharmacist before taking any dosage form that does not match the rest of the bottle, and should follow the instructions issued by the manufacturer.
The recalled product
- Product
- OMEPRAZOLE (OMEPRAZOLE)
- Brand
- OMEPRAZOLE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Delayed-release capsule
- Affected units
- 1,476
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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