Sun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
Sun Pharmaceutical Industries Inc. is recalling Tretinoin Cream USP, 0.05%, 45 g tubes, Lot # AD96183, due to failed impurities and degradation specifications.
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, indicating the product is not likely to cause adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Tretinoin Cream USP, 0.05%, 45 g tubes, manufactured for Northstar Rx LLC and by Taro Pharmaceuticals Inc. The affected product is identified by NDC 16714-249-02, Lot # AD96183, and an expiration date of 12/31/2026.
The recall was initiated because the product failed impurities and degradation specifications. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The product was distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for disposal or replacement.
The recalled product
- Product
- TRETINOIN (TRETINOIN)
- Brand
- TRETINOIN
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Topical Prescription
- 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 # AD96183
- Exp Date: 12/31/2026.
Distribution
Distributed nationwide across the United States.
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