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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug

Dr. Reddy's Laboratories, Inc.: Failed dissolution specifications - low dissolution results at S3 stage.

Agency Publication Date: March 2, 2017
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Affected Products

Product: Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India,NDC 55111-137-81

Lot # 01KB60250, Exp 3/18

Lot Numbers:
01KB60250
Product: Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), 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

Lot # KB50877, KB50878, Exp 11/17; KB50878, 01KB60251, Exp 3/18

Lot Numbers:
KB50877
Product: Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 5511-113-81

Lot # KB60036, Exp 12/17

Lot Numbers:
KB60036
Product: Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81

Lot # KB60197, Exp 2/18

Lot Numbers:
KB60197

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76539
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Manufactured In: United States
Units Affected: 4 products (4032 cartons; 12132 cartons; 4014 cartons; 4404 cartons)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.