Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is ZINC OXIDE recalled?

The FDA has recorded 8 recalls of ZINC OXIDE (2024–2025) , recalled under brands like DYNASHIELD, IMPECCABLE SKIN - IVORY, NIVAGEN ZINC OXIDE. 8 still ongoing.

1
Class I (most serious)
7
Class II
0
Class III
8
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of ZINC OXIDE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

cGMP deviations 6
CGMP Deviations 1
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Sunt Class I ongoing
SYNCHRONICITY SPA INC, DBA SUNTE 2024-05-24 lots: Lot#: 115BU, Exp: 06/30/2025;
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceut Class II ongoing
Blossom Pharmaceuticals 2025-10-31 lots: Lot #: A502404, Exp. Date 2/27; A502405, Exp. Date 2/27; AS02502, Exp. Date 2/28.
Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, M Class II ongoing
Blossom Pharmaceuticals 2025-10-31 lots: Lot #: A352318
Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeb Class II ongoing
Blossom Pharmaceuticals 2025-10-31 lots: Lot #: A092334, Exp. Date 6/26 & A092421, Exp. Date 7/27
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Ma Class II ongoing
Blossom Pharmaceuticals 2025-10-31 lots: Lot #: A092421, Exp. Date 7/27, A092340, Exp. Date 10/26 & A092346, Exp. Date 11/26.
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA Class II ongoing
Blossom Pharmaceuticals 2025-10-31 lots: Lot #: A352505
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in In Class II ongoing
Blossom Pharmaceuticals 2025-10-31 lots: Lot #: A352405
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56 Class II ongoing
SYNCHRONICITY SPA INC, DBA SUNTE 2024-05-24 lots: Lot: a) 107IV, Exp: 04/30/2025 b) 107NU, Exp: 06/30/2025; 109NU, Exp: 10/31/2025 c) 117BU, Exp: 10/31/2025 d) 113SA, Exp: 06/30/2025; 114SA, Exp: 10/31/2025 e) 106BR, Exp: 04/30/2025; f) 101MO, Exp: 05/31/2025

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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