Paricalcitol

Paricalcitol recalls: 5 FDA reports

Recalls involving Paricalcitol. What was wrong with each batch, and how the FDA graded the risk.

5Reports
0Class I
0Ongoing
2016-04-27Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class III4
Class II1

By year reported

YearReports
20121
20164
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064,

D-0833-2016  ·  Class III  ·  reported 2016-04-27  ·  Terminated

Why it was recalled
Failed Content Uniformity Specifications
Product
Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.
Where it went
Nationwide
How much
307 bottles

Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachu

D-0719-2016  ·  Class III  ·  reported 2016-02-24  ·  Terminated

Why it was recalled
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Product
Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30
Where it went
Nationwide
How much
9,155 bottles

Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachu

D-0720-2016  ·  Class III  ·  reported 2016-02-24  ·  Terminated

Why it was recalled
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Product
Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30
Where it went
Nationwide
How much
4383 bottles

Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachu

D-0721-2016  ·  Class III  ·  reported 2016-02-24  ·  Terminated

Why it was recalled
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Product
Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30
Where it went
Nationwide
How much
11,123 bottles

Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by

D-1388-2012  ·  Class II  ·  reported 2012-06-27  ·  Terminated

Why it was recalled
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Product
Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05
Where it went
Nationwide
How much
121,000 vials
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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