Zinc Oxide recalls

The FDA has published 12 recalls involving Zinc Oxide since 2020. The latest was reported on 10 Dec 2025. Most were for manufacturing (cgmp) deviations. Blossom Pharmaceuticals 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 recalls12since 2020

Last 12 months7reported

Class I18% of total

Ongoing9latest 10 Dec 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 7 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 1 8%Class II 8 67%Class III 3 25%

Why zinc oxide is recalled

Companies

Brands

By year

2025758%
2024217%
2020325%

Ongoing zinc oxide recalls

9 active

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Drug	CLASS II	WeCare, Zinc Oxide Ointment recalled by Blossom PharmaceuticalsZinc Oxide	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 Dec 2025Drug	CLASS II	Nivagen, Zinc Oxide Ointment recalled by Blossom PharmaceuticalsNivagen Zinc Oxide	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 Dec 2025Drug	CLASS II	Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 % recalledNivagen Zinc Oxide	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 Dec 2025Drug	CLASS II	Dynashield cream recalled by Blossom PharmaceuticalsDynashield	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 Dec 2025Drug	CLASS II	Dynashield Skin Protectant recalled by Blossom PharmaceuticalsDynashield	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 Dec 2025Drug	CLASS II	Nivagen Pharmaceuticals, Zinc Oxide Ointment recalledNivagen Zinc Oxide	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

All zinc oxide recalls, newest first

12 total

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Drug	CLASS II	WeCare, Zinc Oxide Ointment recalled by Blossom PharmaceuticalsZinc Oxide	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 Dec 2025Drug	CLASS II	Nivagen, Zinc Oxide Ointment recalled by Blossom PharmaceuticalsNivagen Zinc Oxide	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 Dec 2025Drug	CLASS II	Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 % recalledNivagen Zinc Oxide	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 Dec 2025Drug	CLASS II	Dynashield cream recalled by Blossom PharmaceuticalsDynashield	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 Dec 2025Drug	CLASS II	Dynashield Skin Protectant recalled by Blossom PharmaceuticalsDynashield	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 Dec 2025Drug	CLASS II	Nivagen Pharmaceuticals, Zinc Oxide Ointment recalledNivagen Zinc Oxide	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 Dec 2025Drug	CLASS II	Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant recalledZinc Oxide 20%	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
17 Jul 2024Drug	CLASS I	suntegrity, (Zinc Oxide 15%) Impeccable Skin sunscreen recalledImpeccable Skin - Ivory	Synchronicity SPA Inc	Mold	Nationwide
17 Jul 2024Drug	CLASS II	suntegrity, (Zinc Oxide 15%) Impeccable Skin sunscreen recalledImpeccable Skin - Ivory	Synchronicity SPA Inc	Manufacturing (CGMP) Deviations	Nationwide
20 May 2020Drug	CLASS III	ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen recalledChapstick Total Hydration Moisture Tint Peachy Keen	Glaxosmithkline Consumer Healthcare Holdings	Packaging Defects	Nationwide
20 May 2020Drug	CLASS III	ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink recalledChapstick Total Hydration Moisture Tint Pretty In Pink	Glaxosmithkline Consumer Healthcare Holdings	Packaging Defects	Nationwide
20 May 2020Drug	CLASS III	ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry recalledChapstick Total Hydration Moisture Tint Very Berry	Glaxosmithkline Consumer Healthcare Holdings	Packaging Defects	Nationwide

Should you stop taking Zinc Oxide?

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.