Dr. Reddy's Zenatane 20mg Capsules Recall: Failed Dissolution Specifications
Dr. Reddy's recalls 20mg Zenatane capsules due to failed dissolution specifications. This may affect medication effectiveness. Check NDC numbers and expiration dates for affected lots.
Lower-risk recall
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Contact the company
What happened, in plain English
Dr. Reddy's is recalling 20mg Zenatane capsules that failed dissolution tests. This could mean the medication doesn't work properly, so affected users should check their product details. Read more at govinfonow.com/recall/41600-dr-reddy-s-zenatane-20mg-capsules-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/41600-dr-reddy-s-zenatane-20mg-capsules-recall-failed-dissolution-specifications · Updated October 8, 2026 · FDA enforcement record: FDA #D-0884-2017
Cite this page
“Dr. Reddy's Zenatane 20mg Capsules Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41600-dr-reddy-s-zenatane-20mg-capsules-recall-failed-dissolution-specifications. Based on FDA recall #D-0884-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0884-2017%22&limit=1).
Why it’s dangerous
The capsules failed dissolution specifications, meaning they may not release the medication properly in the body. This could lead to reduced effectiveness of the drug, but does not cause immediate harm or injury.
Who’s affected
Prescription users of Zenatane capsules with specific NDC numbers and expiration dates listed in the recall. Those who have the capsules from the listed lots and expiration dates are most at risk.
How to tell if you have this one
Check for NDC numbers 55111-136-81 and expiration dates listed in the recall (e.g., 05/17, 07/17, 08/17, etc.). The product is a prescription-only capsule.
- 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 II- Status
Terminated- Distribution
Nationwide in the USA and Puerto Rico- NDC
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
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0883-2017 | Zenatane (isotretinoin) Capsules, USP, 10 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 55111-135-81; Lot #: KB50471, Exp 06/17; KB50710, KB50710A, Exp 08/17; KB60198, Exp 02/18 | 13,221 cartons |
| D-0884-2017 | 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; Lot #: KB50361, KB50362, Exp 05/17; KB50540, Exp 07/17; KB50638, KB50639, Exp 08/17; KB50725, KB50726, KB50755, KB50756, Exp 09/17; 01KB60255, 79KB60252, 79KB60253, 79KB60254, Exp 03/18; 01KB60347, 01KB60348, 01KB60349, 01KB60350, 79KB60351, Exp 05/18; 01KB60421, 01KB60422, 01KB60423, 79KB60419, 79KB60420, Exp 06/18 | 89,118 cartons |
| D-0885-2017 | Zenatane (isotretinoin) Capsules, USP, 30 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 55111-113-81; Lot #: KB50414, KB50456, Exp 05/17; KB50457, KB50458, KB50459, KB50460, Exp 06/17; KB50580, KB50581, KB50582, KB50583, KB50599, KB50600, Exp 07/17; KB50646, KB50647, KB50721, KB50722, KB50723, KB50724, Exp 09/17; KB50833, KB50834, KB50835, KB50836, KB50837, Exp 10/17; KB50902, KB50903, KB50904, Exp 11/17; KB60037, KB60038, KB60039, KB60040, KB60041, Exp 12/17; KB60109, KB60110, KB60111, KB60112, KB60113, Exp 01/18; 01KB60249, 01KB60266, 01KB60268, 01KB60269, 01KB60284, Exp 03/18; 01KB60369, 01KB60372, 79KB60368, 79KB60371, Exp 05/18; 79KB60507, 79KB60508, 79KB60509, 79KB60510, 79KB60511, 79KB60512, 79KB60513, 79KB60514, 79KB60515, 79KB60516, Exp 07/18; 79KB60570, 79KB60571, 79KB60585, 79KB60586, Exp 08/18; | 223,650 cartons |
| D-0886-2017 | Zenatane (isotretinoin) Capsules, USP, 40 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 55111-137-81; Lot #: KB50363, KB50364, KB50365, KB50366, KB50367, KB50368, KB50369, KB50370, KB50371, Exp 05/17; 01KB50598, KB50541, KB50542, KB50543, KB50544, KB50545, KB50546, KB50547, KB50548, KB50549, KB50550, KB50551, Exp 07/17; 01KB50643, 01KB50644, KB50640, KB50641, KB50642, KB50645, Exp 08/17; KB50715, KB50716, KB50717, KB50718, KB50719, KB50720, KB50757, KB50758, KB50759, KB50760, KB50761, Exp 09/17; KB50872, KB50874, KB50875, KB50876, KB50916, KB50938, KB50943, Exp 11/17; 01KB60062, 01KB60063, 01KB60064, 01KB60065, 01KB60066, 01KB60101, KB60025, KB60026, KB60027, KB60028, KB60029, KB60030, KB60031, KB60032, KB60059, KB60060, KB60061, Exp 12/17; 01KB60100, 01KB60161, Exp 01/18; 01KB60256, 01KB60257, 01KB60258, 01KB60259, 01KB60260, Exp 03/18; 01KB60292, 01KB60293, 01KB60294, 01KB60314, 01KB60321, 01KB60333, 01KB60334, 79KB60295, 79KB60296, 79KB60332, 79KB60335, 79KB60346, Exp 04/18; 01KB60393, 01KB60394, 79KB60390, 79KB60391, 79KB60392, Exp 05/18; 01KB60505, 01KB60506, 01KB60538, 79KB60502, 79KB60503, 79KB60504, 79KB60535, 79KB60536, 79KB60537, 79KB60539, 79KB60542, Exp 07/18; 01KB60589, 79KB60566, 79KB60567, 79KB60568, 79KB60569, 79KB60587, 79KB60588, Exp 08/18 | 452,290 cartons |
What to do — step by step
Check Product Details
Look for the NDC number 55111-136-81 and expiration dates matching those listed in the recall (e.g., 05/17, 07/17, 08/17).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this product?
Check the NDC number and expiration date to see if it matches the recalled lots listed in the notice. If it does, you may want to contact your doctor.
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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-0884-2017 (May 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0884-2017 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.