Prescription medicine
Zinc sulfate
Zinc sulfate is a prescription medicine with an FDA approval on record since 1987. FDA's NDC Directory lists it from 8 generic labelers.
- Generic listed
Check it at the source: the zinc sulfate FDA label on DailyMed (effective October 1, 2020, American Regent, Inc.); the NDA 19229 record on Drugs@FDA; every zinc sulfate label on DailyMed.
Highlights of the record
FDA label of October 1, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Forms and strengths
- 1 mg/ml
- 3 mg/ml
- 5 mg/ml
- 25 mg/5ml
- 30 mg/10ml
Injection (solution); solution; injection.
On the market
- Earliest approval on file
- May 5, 1987 Zinc Sulfate, Abraxis Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first May 3, 2022; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 8 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest July 30, 2025; 11 more by firms not listed as its makers
- FAERS reports
- 2,808 through July 30, 2026
What is zinc sulfate used for?
From the label: indications and usageZinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Zinc Sulfate Injection is a trace element indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
FDA pharmacologic class: Copper Absorption Inhibitor.
Source: FDA drug label (Zinc Sulfate), American Regent, Inc., effective October 1, 2020 (SPL set 4b528c88-07a0-4dce-84c6-ccd32555bbff), via openFDA; the full label on DailyMed
Is there a generic for zinc sulfate?
The FDA approved the first generic zinc sulfate on May 3, 2022. 8 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists zinc sulfate from 8 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1987 earliest approval on file
- 2022 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has zinc sulfate been recalled?
The FDA's Enforcement Report lists 13 recalls naming zinc sulfate since 2013: 0 Class I (the most serious), 13 Class II, 0 Class III; 1 still ongoing. 11 of them are by firms that FDA's NDC Directory does not list as a maker of zinc sulfate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 30, 2025 | Class II | GenoGenix LLC | Lack of Assurance of Sterility |
| June 19, 2019 | Class II | RXQ Compounding LLC not a listed maker | Lack of Assurance of Sterility |
| December 17, 2018 | Class II | Promise Pharmacy, LLC not a listed maker | Lack of sterility assurance. |
| September 10, 2018 | Class II | Pharm D Solutions, LLC | Lack of Assurance of Sterility |
| October 16, 2015 | Class II | Downing Labs, LLC not a listed maker | Lack of Assurance of Sterility |
| September 12, 2015 | Class II | US Compounding Inc not a listed maker | 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 … |
| July 26, 2013 | Class II | Beacon Hill Medical Pharmacy, P.C. not a listed maker | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) may be potentially mislabeled as PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for zinc sulfate?
The FDA Adverse Event Reporting System holds 2,808 reports that list zinc sulfate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 390 are coded as a death and 1,264 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Alternatives to zinc sulfate
- medicines labeled for the same conditions
- Other copper absorption inhibitors
- the pharmacologic class, with prices and generics
- Zinc sulfate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other