The Recall Desk
ModerateFDA (Drugs)·D-0508-2017·Announced 2017-03-08

Dr. Reddy's Recalls Zenatane Capsules for Dissolution Failure

Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) 30 mg capsules because they failed to meet dissolution specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. A score of 2 is assigned as it involves a functional defect (dissolution failure) rather than a purely cosmetic or documentation issue.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling 4,014 cartons of Zenatane (isotretinoin) capsules, 30 mg. The affected product is packaged in 30-count cartons and is identified by Lot # KB60036 with an expiration date of 12/17. The product was distributed nationwide in the United States.

The recall was initiated because the product failed to meet dissolution specifications, specifically showing low dissolution results at the S3 stage. Dissolution is a critical quality attribute that ensures the medication releases its active ingredient properly in the body.

Consumers who have this specific lot of Zenatane should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment. The recall is classified as Class III by the FDA, indicating that the product is unlikely to cause adverse health consequences.

The recalled product

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
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
4,014

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # KB60036
  • Exp 12/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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Same manufacturer · Dr. Reddy's Laboratories, Inc.

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