Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Zenatane (isotretinoin) Capsules Recalled by Dr. Reddy's Laboratories, Inc. Due to Failed Dissolution Specifications: out of specification results observed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Dr. Reddy's Laboratories, Inc. directly.
Affected Products
Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
Quantity: 89,118 cartons
Why Was This Recalled?
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Dr. Reddy's Laboratories, Inc.
Dr. Reddy's Laboratories, Inc. has 163 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report