The Recall Desk
ModerateFDA (Drugs)·D-0886-2017·Announced 2017-06-14

Dr. Reddy's Recalls Zenatane Capsules for Low Dissolution

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

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, and the hazard involves a quality specification failure (dissolution) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Zenatane (isotretinoin) Capsules, USP, 40 mg. The recall involves 452,290 cartons of the prescription medication, which were distributed nationwide in the USA and Puerto Rico.

The recall was initiated because out-of-specification results were observed for low dissolution. This means the capsules may not dissolve properly in the body, potentially affecting how the medication is absorbed.

Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement.

The recalled product

Product
ZENATANE (ISOTRETINOIN)
Brand
ZENATANE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
452,290

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 #: KB50363
  • KB50364
  • KB50365
  • KB50366
  • KB50367
  • KB50368
  • KB50369
  • KB50370
  • KB50371
  • Exp 05/17
  • 01KB50598
  • KB50541
  • KB50542
  • KB50543
  • KB50544
  • KB50545
  • KB50546
  • KB50547
  • KB50548
  • KB50549

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 →