Dr. Reddy's Zenatane 10mg Capsules Recall: Low Dissolution Risk
Dr. Reddy's recalls 10mg Zenatane capsules due to failed dissolution at S3 stage. This may affect medication effectiveness. Check your prescription for affected lots.
Lower-risk recall
Failed dissolution specifications - low dissolution results at S3 stage.
Contact the company
What happened, in plain English
Dr. Reddy's is recalling 10mg Zenatane capsules that may not dissolve properly, potentially reducing medication effectiveness. This recall affects prescription-only products sold in specific lots. Read more at govinfonow.com/recall/41945-dr-reddy-s-zenatane-10mg-capsules-recall-low-dissolution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41945-dr-reddy-s-zenatane-10mg-capsules-recall-low-dissolution-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0509-2017
Cite this page
“Dr. Reddy's Zenatane 10mg Capsules Recall: Low Dissolution Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41945-dr-reddy-s-zenatane-10mg-capsules-recall-low-dissolution-risk. Based on FDA recall #D-0509-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0509-2017%22&limit=1).
Why it’s dangerous
The capsules fail to dissolve properly at the S3 stage, which could lead to reduced medication effectiveness. This issue is specific to the manufacturing process and does not cause immediate harm.
Who’s affected
Prescription holders of Zenatane 10mg capsules with lot number KB60197 (expiring 2/18) are affected. Patients using these capsules for acne treatment are most at risk.
How to tell if you have this one
Check for Zenatane 10mg capsules in 30-count cartons (3 x 10 blister cards) with lot number KB60197, expiring February 2018. These were manufactured by Cipla Limited in India and distributed by Dr. Reddy's Laboratories.
- Brand
Dr. Reddy's- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
U.S. Nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0506-2017 | 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 | 4032 cartons | 55111-135-79, 55111-135-81, 55111-136-79, 55111-136-81, 55111-137-79, 55111-137-81, 55111-113-79, 55111-113-81, 55111-113-78 |
| D-0507-2017 | 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 | 12132 cartons | 55111-135-79, 55111-135-81, 55111-136-79, 55111-136-81, 55111-137-79, 55111-137-81, 55111-113-79, 55111-113-81, 55111-113-78 |
| D-0508-2017 | 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 | 4014 cartons | — |
| D-0509-2017 | 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 | 4404 cartons | 55111-135-79, 55111-135-81, 55111-136-79, 55111-136-81, 55111-137-79, 55111-137-81, 55111-113-79, 55111-113-81, 55111-113-78 |
What to do — step by step
Check Product Details
Identify if your Zenatane 10mg capsules have lot number KB60197, expiring February 2018.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0509-2017 (February 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0509-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.