Dr. Reddy's Recalls Zenatane Capsules for Dissolution Failure
Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because they failed to meet dissolution specifications. The affected lot is distributed nationwide.
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 III, which indicates the product is not likely to cause adverse health consequences. The failure is a quality control issue (dissolution) rather than a direct safety hazard like contamination or mislabeling of a critical allergen.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons. The recall involves 4,032 cartons of the product, which is distributed nationwide in the United States.
The recall was initiated because the product failed to meet dissolution specifications, specifically showing low dissolution results at the S3 stage. The affected product is identified by Lot # 01KB60250 and has an expiration date of 3/18.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider regarding alternative treatment options if they have been using this specific lot.
The recalled product
- Product
- ZENATANE (ISOTRETINOIN)
- Brand
- ZENATANE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 4,032
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 # 01KB60250
- Exp 3/18
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
- ModerateDr. Reddy's Recalls Zenatane Capsules for Low Dissolution
FDA (Drugs) · 2017-06-14
- ModerateDr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures
FDA (Drugs) · 2017-06-14
- ModerateDr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failure
FDA (Drugs) · 2017-06-14
- ModerateDr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures
FDA (Drugs) · 2017-06-14
- LowDr. Reddy's Recalls Zenatane Capsules Due to Dissolution Failure
FDA (Drugs) · 2017-03-08
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