The Recall Desk
ModerateFDA (Drugs)·D-0883-2017·Announced 2017-06-14

Dr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures

Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.

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 II, which the rubric associates with moderate severity when no hospitalizations or serious injuries are reported. The hazard is a quality defect (dissolution) that may reduce efficacy rather than cause direct acute harm.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Zenatane (isotretinoin) Capsules, USP, 10 mg. The recall involves 13,221 cartons of the prescription medication, which was distributed nationwide in the USA and Puerto Rico. The specific lots affected are KB50471 (Exp 06/17), KB50710 and KB50710A (Exp 08/17), and KB60198 (Exp 02/18).

The recall was initiated because out-of-specification results were observed for low dissolution. Dissolution is a critical quality attribute that ensures the drug releases properly in the body; if the capsules do not dissolve as intended, the medication may not be absorbed effectively, potentially reducing its therapeutic efficacy.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If you have these products, you should stop using them and contact your pharmacist or Dr. Reddy's Laboratories for instructions on how to return the medication for a refund or replacement.

The recalled product

Product
ZENATANE (ISOTRETINOIN)
Brand
ZENATANE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
13,221

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 (7)

  • Lot #: KB50471
  • Exp 06/17
  • KB50710
  • KB50710A
  • Exp 08/17
  • KB60198
  • Exp 02/18

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Related recalls

Same brand · ZENATANE

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

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Same hazard · dissolution failure

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