The Recall Desk
ModerateFDA (Drugs)·D-0884-2017·Announced 2017-06-14

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

Dr. Reddy's 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) without reported injuries or illnesses, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Zenatane (isotretinoin) Capsules, USP, 20 mg. The recall involves 89,118 cartons of the prescription medication, which was distributed nationwide in the USA and Puerto Rico. The product is manufactured by Cipla Limited in India for Dr. Reddy's Laboratories.

The recall was initiated because out-of-specification results were observed for low dissolution. Dissolution is a critical quality attribute that determines how quickly a drug releases its active ingredient in the body; failure to meet these specifications may result in the medication not being absorbed as intended.

Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or contact Dr. Reddy's Laboratories for further instructions. The specific lot numbers and expiration dates are listed in the official recall notice.

The recalled product

Product
ZENATANE (ISOTRETINOIN)
Brand
ZENATANE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
89,118

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 #: 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

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.

See all →

Same hazard · dissolution failure

See all →