The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0509-2017·Announced 2017-03-08

Dr. Reddy's Recalls Zenatane Capsules Due to Dissolution Failure

Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because they failed to meet dissolution specifications. The recall covers 4,404 cartons distributed nationwide.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons. The recall involves 4,404 cartons of the medication, which was distributed nationwide in the United States. The specific lot affected is KB60197, with an expiration date of 2/18.

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 breaks down properly in the body to be absorbed effectively.

Consumers who have this specific lot of Zenatane should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that the violation of the product's labeling or manufacturing specifications is not likely to cause adverse health consequences.

The recalled product

Product
ZENATANE (ISOTRETINOIN)
Brand
ZENATANE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
4,404

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 # KB60197
  • Exp 2/18

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 →

Related recalls

Same brand · ZENATANE

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

See all →

Same hazard · dissolution failure

See all →

Similar recalls