AbbVie Recalls Zemplar Capsules for Failed Content Uniformity Specifications
AbbVie is recalling 307 bottles of Zemplar (paricalcitol) capsules nationwide because the product failed content uniformity specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification failures.
Plain-English summary
AbbVie Inc. is recalling 307 bottles of Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottles. The recall is being conducted because the product failed content uniformity specifications. The affected product is identified by Lot #1055586 with an expiration date of 1/21/2018.
The recall is classified as Class III by the U.S. Food and Drug Administration. The product was distributed nationwide. Zemplar is a prescription-only medication used to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Patients and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The recall number is D-0833-2016.
The recalled product
- Product
- ZEMPLAR (PARICALCITOL)
- Brand
- ZEMPLAR
- Manufacturer
- AbbVie Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 307
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #1055586
- Exp.1/21/ 2018
UPCs (2)
- 0300749036309
- 0300749037306
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ZEMPLAR
- SevereAbbott Recalls Zemplar Injection Due to Potential Foreign Stopper Contamination
FDA (Drugs) · 2012-06-27
Same manufacturer · AbbVie Inc.
See all →- ModeratePred Mild prednisolone eye suspension failed stability specifications
FDA (Drugs) · 2026-06-03
- HighRefresh LACRI-LUBE Eye Ointment Recalled for Potential Tube Seal Breach
FDA (Drugs) · 2024-10-02
- HighFDA Recalls Refresh P.M. Eye Ointment Due to Potential Sterility Breach
FDA (Drugs) · 2024-10-02
- HighSynthroid Levothyroxine Tablets Recalled for Incorrect Barcode Labeling
FDA (Drugs) · 2023-11-15
- LowAbbVie Recalls Ultane Sevoflurane Due to Defective Container Caps
FDA (Drugs) · 2018-02-07
Same hazard · content uniformity
See all →- ModeratePreferred Pharmaceuticals Recalls Lidocaine Ointment Due to Content Uniformity Failures
FDA (Drugs) · 2026-10-14
- ModerateLupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
FDA (Drugs) · 2026-09-02
- HighOral contraceptive tablets recalled after failing content uniformity specifications
FDA (Drugs) · 2025-10-15
- HighCefixime Oral Suspension Recalled for Failed Content Uniformity Specifications
FDA (Drugs) · 2024-06-26
- SevereFDA Recalls Phenytoin Oral Suspension Due to Content Uniformity Failure
FDA (Drugs) · 2023-12-27
Similar recalls
- SevereAbbott Recalls Zemplar Injection Due to Potential Foreign Stopper Contamination
FDA (Drugs) · 2012-06-27
- ModerateAidapak Recalls Paricalcitol Capsules Due to Potential Labeling Errors
FDA (Drugs) · 2014-01-29
- LowTeva Recalls Paricalcitol Capsules Due to Impurity Test Failures
FDA (Drugs) · 2016-10-26
- HighParoxetine Hydrochloride Tablets Recalled for Out-of-Specification Impurity
FDA (Drugs) · 2023-12-06
- LowPfizer Recalls Advil PM Caplets Due to Low Diphenhydramine Levels
FDA (Drugs) · 2014-03-26
- LowDr. Reddy's Recalls Paricalcitol Capsules Due to Breakage and Leakage
FDA (Drugs) · 2016-02-24