Omeprazole Delayed-release Capsules recall
FDA recall D-0525-2025 · initiated Jun 30, 2025
Dr. Reddy's Laboratories, Inc. recalled Omeprazole Delayed-release Capsules in Jun 2025 — an FDA Class II recall (D-0525-2025) because Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1476 bottles
Details
- Product
- Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
- Recalling company
- Dr. Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jun 30, 2025
- FDA report date
- Jul 23, 2025
Frequently asked
- Was Omeprazole Delayed-release Capsules recalled?
- Dr. Reddy's Laboratories, Inc. recalled Omeprazole Delayed-release Capsules in Jun 2025 — an FDA Class II recall (D-0525-2025) because Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Omeprazole Delayed-release Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0525-2025 was: Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
- Is a recalled Omeprazole Delayed-release Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Omeprazole Delayed-release Capsules are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot: C2403017, Exp 12/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0525-2025.