Class II · Moderate risk
Zinc Sulfate
Lack of Assurance of Sterility
Is Zinc recalled?
Yes — there is an active recall. 47 ongoing FDA recalls mention Zinc (156 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Zinc. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Zinc recalls on record
none so far in 2026; 156 on record, newest first
Class II · Moderate risk
Zinc Sulfate
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Trace Elements-4
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Zinc Chloride 25mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Zinc 5 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 2:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class III · Low risk
Z-Cote Hp 1 Transparent Zinc Oxide
Labeling: Illegible label. Writing is rubbing off of labels.
Class III · Low risk
Eye Drops A.C.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk
Zinc Pyrithione active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Z-Cote Hp 1 Transparent Zinc Oxide
cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
Class II · Moderate risk
Dermatend Ultra
Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.
Class II · Moderate risk
Dermatend Original
Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.
Class II · Moderate risk
Multitrace-4 pediatric injection
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Class II · Moderate risk
Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vanilla
Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
Class II · Moderate risk
Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula
Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
Class II · Moderate risk
Zinc Sulfate 1 mg/ml INJECTABLE
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
ZINC SULFATE Capsule
Labeling:Label Mixup; ZINC SULFATE Capsule, 220 mg may be potentially mislabeled as CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD52778_10, EXP: 5/20/2014; CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: W003638, EXP: 6/25/2014.
Class II · Moderate risk
Zinc Sulfate
Labeling: Label Mixup; ZINC SULFATE, Capsule, 50 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD30993_14, EXP: 5/9/2014.
Class II · Moderate risk
Zinc Sulfate
Labeling: Label Mixup; ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) may be potentially mislabeled as PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD56916_1, EXP: 5/21/2014.
Class II · Moderate risk
Zinc Gluconate
Labeling: Label Mixup; ZINC GLUCONATE, Tablet, 50 mg may be potentially mis-labeled as ASCORBIC ACID, Chew Tablet, 500 mg, NDC 00904052660, Pedigree: AD60240_54, EXP: 5/22/2014 and ASCORBIC ACID, Chew Tablet, 250 mg, NDC 00904052260, Pedigree: W003027, EXP: 6/12/2014.
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