Prescription medicine
Zinc chloride
Zinc chloride is a prescription medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the zinc chloride FDA label on DailyMed (effective August 3, 2026, Exela Pharma Sciences,LLC); the NDA 18959 record on Drugs@FDA; every zinc chloride label on DailyMed.
Highlights of the record
FDA label of August 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZinc Chloride Injection, USP, 1 mg/mL is indicated for use as a supplement to intravenous solutions given for TPN.
Forms and strengths
- 1 mg/ml
Injection; injection (solution).
On the market
- Earliest approval on file
- June 26, 1986 Zinc Chloride In Plastic Container, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first May 21, 2021; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 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)
- 1 since 2012 0 Class I among all firms' recalls; latest July 30, 2025; 5 more by firms not listed as its makers
- FAERS reports
- 24,686 through July 30, 2026
What is zinc chloride used for?
From the label: indications and usageZinc Chloride Injection, USP, 1 mg/mL is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain zinc serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.
FDA pharmacologic class: Copper Absorption Inhibitor.
Source: FDA drug label (Zinc Chloride), Exela Pharma Sciences,LLC, effective August 3, 2026 (SPL set 2bd646d2-2a2a-4376-8da0-c7f08b0511ac), via openFDA; the full label on DailyMed
Is there a generic for zinc chloride?
The FDA approved the first generic zinc chloride on May 21, 2021. 3 generic applications are approved; 3 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 chloride from 2 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.
- 1986 earliest approval on file
- 2021 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has zinc chloride been recalled?
The FDA's Enforcement Report lists 6 recalls naming zinc chloride since 2012: 0 Class I (the most serious), 6 Class II, 0 Class III; 1 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of zinc chloride 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 |
| May 9, 2022 | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy not a listed maker | Lack of assurance of sterility. |
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical not a listed maker | Lack of Assurance of Sterility |
| May 13, 2016 | Class II | Medaus, Inc. not a listed maker | Lack of Assurance of Sterility |
| June 2, 2015 | Class II | The Compounding Pharmacy of America not a listed maker | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility |
| May 21, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for zinc chloride?
The FDA Adverse Event Reporting System holds 24,686 reports that list zinc chloride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,507 are coded as a death and 6,172 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?
- Other copper absorption inhibitors
- the pharmacologic class, with prices and generics
- Zinc chloride side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other