Tretinoin recalls

The FDA has published 8 recalls involving Tretinoin since 2017. The latest was reported on 14 Oct 2026. Most were for potency & assay. SUN Pharmaceutical Industries has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls8since 2017

Last 12 months3reported

Class I00% of total

Ongoing3latest 14 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 3 0

Severity split

Class I 0 0%Class II 5 63%Class III 3 38%

Why tretinoin is recalled

Companies

By year

2026338%
2022225%
2020113%
2017225%

Ongoing tretinoin recalls

3 active

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS III	Tretinoin Cream USP, 0.05% tube recalledTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS III	Tretinoin Cream UPS recalled by SUN Pharmaceutical IndustriesTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS III	Tretinoin Cream USP, 0.05% tube recalledTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide

All tretinoin recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS III	Tretinoin Cream USP, 0.05% tube recalledTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS III	Tretinoin Cream UPS recalled by SUN Pharmaceutical IndustriesTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS III	Tretinoin Cream USP, 0.05% tube recalledTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
29 Jun 2022Drug	CLASS II	Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals USA	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
9 Feb 2022Drug	CLASS II	Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals U	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
22 Apr 2020Drug	CLASS II	Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm recalled	The Medicine Shoppe Pharmacy	Other	FL
22 Mar 2017Drug	CLASS II	Tretinoin 0.02% In Oil Free Cream recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017Drug	CLASS II	Tretinoin Cream in all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide

Should you stop taking Tretinoin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.