The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0098-2017·Announced 2016-10-19

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

Dr. Reddy's Laboratories is recalling ZENATANE (isotretinoin) 20 mg capsules because they failed to meet dissolution specifications. The recall covers 3,858 prescription packs 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 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.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling ZENATANE (isotretinoin) 20 mg capsules, 30 capsules per prescription pack. The recall involves 3,858 prescription packs, totaling 115,680 capsules, which were distributed nationwide. The affected product is identified by Lot # 79KB60205 and has an expiration date of 02/18.

The recall was initiated because the product failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the appropriate rate in the body. When this specification is not met, the medication may not work as intended.

Consumers and healthcare providers should stop using the affected ZENATANE capsules and return them to their pharmacy or contact Dr. Reddy's Laboratories for further instructions. This recall is classified as Class III by the FDA, indicating that the violation 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 Drug
Hazard

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 # 79KB60205
  • Exp. 02/18

Distribution

Distributed nationwide across the United States.

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