Drug & medication recalls Moderate risk

Dr. Reddy's Laboratories, Inc. recalls Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories L…

Recall date
June 30, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0525-2025
FDA classification
Class II
Brand / firm
Dr. Reddy's Laboratories, Inc.
Sold / distributed
USA Nationwide

Why it was recalled

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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