Dr. Reddy's Recalls Zenatane Capsules Due to Dissolution Failures
Dr. Reddy's Laboratories is recalling specific lots of Zenatane (isotretinoin) 20 mg capsules because they 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 III, which indicates the product is not likely to cause adverse health consequences. The failure to meet dissolution specifications is a quality control issue that may affect efficacy but does not present an immediate safety hazard like contamination or mislabeling.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 12,132 cartons of Zenatane (isotretinoin) 20 mg capsules. The affected product is packaged in 30-count cartons and 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 lots are KB50877 and KB50878 with an expiration date of 11/17, and lot KB50878 and 01KB60251 with an expiration date of 3/18.
Consumers who have these specific lots of Zenatane should stop using the product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- ZENATANE (ISOTRETINOIN)
- Brand
- ZENATANE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 12,132
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 (5)
- Lot # KB50877
- KB50878
- Exp 11/17
- 01KB60251
- 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 Isotretinoin Capsules for Dissolution Failures
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 Capsules for Low Dissolution
FDA (Drugs) · 2017-06-14
- ModerateDr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failure
FDA (Drugs) · 2017-06-14
- LowDr. Reddy's Recalls Zenatane Capsules Due to Dissolution Failure
FDA (Drugs) · 2017-03-08
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