The Recall Desk
ModerateFDA (Drugs)·D-0885-2017·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 is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling of a dangerous substance, fitting the Moderate category for low-risk quality issues without reported injuries.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count cartons. The recall involves 223,650 cartons distributed nationwide in the USA and Puerto Rico. The specific lots affected are identified by various lot numbers and expiration dates ranging from May 2017 to August 2018, as detailed in the recall notice.

The reason for the recall is that out-of-specification results were observed for low dissolution. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the expected rate. If the capsules do not dissolve properly, the medication may not be absorbed by the body as intended, potentially leading to reduced therapeutic efficacy.

Consumers and healthcare providers should stop using the affected lots of Zenatane and contact their pharmacist or Dr. Reddy's Laboratories for a replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
ZENATANE (ISOTRETINOIN)
Brand
ZENATANE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
223,650

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 (20)

  • 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

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 · quality control failure

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