CLASS III Drug recall · Reported 24 Feb 2016 · FDA Enforcement Report
Paricalcitol Capsules, 4 mcg recalled by Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is recalling Paricalcitol Capsules, 4 mcg per, distributed nationwide in the US. The recall was initiated on 4 Nov 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0721-2016
- FDA event ID
- 72648
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Paricalcitol
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Nov 2015
- FDA classified
- 18 Feb 2016
- Reported
- 24 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Vitamins & OTC Supplements
Timeline
| 4 Nov 2015 | Recall initiated by company | |
| 18 Feb 2016 | Classified by FDA | +106 days |
| 24 Feb 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Which lots are affected?
Lot #s: C404440, Exp 04/2016; C404946, Exp 05/2016; C505704, Exp 07/2017
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 72648This product is part of a recall event; the main page for the event is Paricalcitol Capsules, 1 mcg recalled by Dr. Reddy's Laboratories.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Paricalcitol Capsules, 1 mcg recalled by Dr. Reddy's LaboratoriesParicalcitol | Dr. Reddy's Laboratories | Packaging Defects | Nationwide | |
| CLASS III | Paricalcitol Capsules, 2 mcg recalled by Dr. Reddy's LaboratoriesParicalcitol | Dr. Reddy's Laboratories | Packaging Defects | Nationwide |
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Paricalcitol recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Paricalcitol Capsules, 1 mcg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Paricalcitol Capsules, 4 mcg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Paricalcitol Capsules, 2 mcg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Paricalcitol Capsules, 1 mcg recalled by Amerisource Health Services | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Zemplar (paricalcitol) capsules, 1 mcg recalled by AbbVieZemplar | AbbVie | Other | Nationwide |