Prescription medicine
Calcium acetate First approved as Phoslo
Calcium acetate (Phoslo) is a prescription medicine with an FDA approval on record since 1990. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $0.170 per calcium acetate 667 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the calcium acetate FDA label on DailyMed (effective July 1, 2025, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the NDA 19976 record on Drugs@FDA; every calcium acetate label on DailyMed.
Highlights of the record
FDA label of July 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCalcium acetate capsule is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.
Forms and strengths
- 667 mg
Capsule; tablet.
On the market
- Earliest approval on file
- December 10, 1990 Phoslo, Fresenius Medcl Care; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first January 30, 2008; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 20 of which 20 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- February 23, 2030 Phoslyra oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.170 per capsule Calcium acetate 667 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest March 15, 2021; 2 more by firms not listed as its makers
- FAERS reports
- 5,355 through July 30, 2026
What is calcium acetate used for?
From the label: indications and usageCalcium acetate capsule is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. ( 1 ) Calcium acetate capsule is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
FDA pharmacologic class: Blood Coagulation Factor and Phosphate Binder.
Source: FDA drug label (calcium acetate), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective July 1, 2025 (SPL set d48c66a9-26fe-4e1a-a68a-88afe83fb51d), via openFDA; the full label on DailyMed
Is there a generic for calcium acetate (Phoslo)?
The FDA approved the first generic calcium acetate on January 30, 2008. 15 generic applications are approved; 9 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 calcium acetate from 20 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Phoslo tablets; a patent listed only for Phoslyra oral solution runs to February 23, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1990 earliest approval on file
- 2008 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for calcium acetate (Phoslo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.170 per Calcium acetate 667 mg capsule, down 19% from $0.210 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Calcium acetate 667 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Calcium acetate 667 mg capsule | Generic | $0.170 per capsule | $5.09 | -19% |
| Calcium acetate 667 mg tablet | Generic | $0.439 per tablet | $13.16 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has calcium acetate been recalled?
The FDA's Enforcement Report lists 4 recalls naming calcium acetate since 2013: 0 Class I (the most serious), 3 Class II, 1 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of calcium acetate 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 |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| February 13, 2018 | Class III | Nostrum Laboratories Inc | Presence of Foreign Tablets/Capsules |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: CALCIUM ACETATE, Capsule, 667 mg may be potentially mislabeled as one of the following drugs: ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: CALCIUM ACETATE, Tablet, 667 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the calcium acetate label say about other medicines?
The calcium acetate label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 2 other medicines name calcium acetate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ciprofloxacin | drug interactions | In a study of 15 healthy subjects, a co-administered single dose of 4 calcium acetate tablets approximately 2.7 g, decreased the bioavailability of ciprofloxacin by approximately 50%. |
Other labels that name calcium acetate
Source: FDA drug label (calcium acetate), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective July 1, 2025 (SPL set d48c66a9-26fe-4e1a-a68a-88afe83fb51d), via openFDA; the full label on DailyMed
What do FAERS reports show for calcium acetate?
The FDA Adverse Event Reporting System holds 5,355 reports that list calcium acetate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 685 are coded as a death and 2,269 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 blood coagulation factors
- the pharmacologic class, with prices and generics
- Calcium acetate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other