Zinc Oxide recalls: 11 FDA reports
Recalls involving Zinc Oxide. What was wrong with each batch, and how the FDA graded the risk.
11Reports
1Class I
8Ongoing
2025-12-10Most recent
1 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta
D-0212-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- cGMP deviations
- Product
- Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.
- Where it went
- USA Nationwide
- How much
- 33000 containers
Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made i
D-0206-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- cGMP deviations
- Product
- Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.
- Where it went
- USA Nationwide
- How much
- 912 containers
Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Stree
D-0202-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- cGMP deviations
- Product
- Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.
- Where it went
- USA Nationwide
- How much
- 1560 containers
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 1085
D-0207-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- cGMP deviations
- Product
- Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.
- Where it went
- USA Nationwide
- How much
- 7944 containers
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacra
D-0209-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- cGMP deviations
- Product
- Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
- Where it went
- USA Nationwide
- How much
- 7920 bottles
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA
D-0208-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- cGMP deviations
- Product
- Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.
- Where it went
- USA Nationwide
- How much
- 13536 containers
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net
D-0589-2024 · Class II · reported 2024-07-17 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 - IVORY b) NDC: 69949-156-01, UPC: 854245006224 - NUDE c) NDC: 69949-152-01, UPC: 854245006187 - BUFF d) NDC: 69949-153-01, UPC: 854245006194 - SAND e) NDC: 69949-155-01, UPC: 854245006217 - BRONZE f) NDC: 69949-157-01, UPC: 854245006446 - MOCHA
- Where it went
- Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
- How much
- 8202 tubes
Class I
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.
D-0588-2024 · Class I · reported 2024-07-17 · Ongoing
- Why it was recalled
- Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
- Product
- suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
- Where it went
- Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
- How much
- 1,902 tubes
ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madi
D-1267-2020 · Class III · reported 2020-05-20 · Terminated
- Why it was recalled
- Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
- Product
- ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0872-08
- Where it went
- Nationwide
- How much
- 288 packages
ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, M
D-1268-2020 · Class III · reported 2020-05-20 · Terminated
- Why it was recalled
- Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
- Product
- ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0873-08
- Where it went
- Nationwide
- How much
- 360 packages
ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madi
D-1266-2020 · Class III · reported 2020-05-20 · Terminated
- Why it was recalled
- Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
- Product
- ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08
- Where it went
- Nationwide
- How much
- 288 packages
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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