Northstar Rx Recalls Tretinoin Cream Due to Impurities
Northstar Rx LLC recalls specific lots of Tretinoin Cream USP 0.05% due to failed impurity specifications. Check your lot number immediately.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications
What happened, in plain English
Northstar Rx LLC is recalling Tretinoin Cream USP, 0.05%, in 45 g tubes manufactured by Taro Pharmaceuticals Inc. The recall was initiated because the product failed impurities and degradation specifications. This means the chemical composition of the cream may not meet required safety standards. Read more at govinfonow.com/recall/1622871-sun-pharmaceutical-industries-inc-recalls-tretinoin-cream-usp-0-05.
Source Summary by GovInfoNow · govinfonow.com/recall/1622871-sun-pharmaceutical-industries-inc-recalls-tretinoin-cream-usp-0-05 · Published October 21, 2026 · Updated October 21, 2026 · FDA enforcement record: FDA #D-0034-2027
Cite this page
“Northstar Rx Recalls Tretinoin Cream Due to Impurities.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1622871-sun-pharmaceutical-industries-inc-recalls-tretinoin-cream-usp-0-05. Based on FDA recall #D-0034-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0034-2027%22&limit=1).
Why it’s dangerous
The cream failed impurities and degradation specifications, meaning it may contain unexpected chemical byproducts or have degraded beyond acceptable limits. While the record does not specify exact injuries, using pharmaceutical products with failed impurity specs can lead to unpredictable effects or reduced efficacy.
Who’s affected
Consumers who purchased Tretinoin Cream USP, 0.05%, in 45 g tubes distributed nationwide in the United States are affected. Individuals using this specific medication for skin conditions are at risk of using a product that does not meet purity standards.
How to tell if you have this one
Check your tube for the label 'Tretinoin Cream USP, 0.05%, 45 g tube'. Verify the lot number is AD96183 and the expiration date is 12/31/2026. The product was manufactured by Taro Pharmaceuticals Inc. in Canada and distributed nationwide.
- Brand
Northstar Rx- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Ongoing- Distribution
US Nationwide.
| Recall number | Product, codes & lots |
|---|---|
| D-0033-2027 | Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.; Lot # AD96184, Exp Date: 12/31/2026. |
| D-0034-2027 | Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02.; Lot # AD96183, Exp Date: 12/31/2026. |
| D-0035-2027 | Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-0.; Lot # AD96196, Exp Date: 12/31/2026. |
What to do — step by step
Check Your Lot Number
Look at your Tretinoin Cream tube to see if the lot number is AD96183.
Contact Manufacturer
Since no remedy is stated in the record, contact Northstar Rx LLC or Taro Pharmaceuticals Inc. for instructions on what to do with the product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0034-2027 (September 25, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0034-2027 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.