Abbott Recalls Zemplar Injection Due to Potential Foreign Stopper Contamination
Abbott Laboratories is recalling Zemplar (paricalcitol) Injection due to a potential CGMP deviation where a foreign stopper may have been applied to vials.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of foreign object contamination in an injectable medication.
Plain-English summary
Abbott Laboratories is recalling Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials. The recall involves 121,000 vials from Lot # 11-122-DK, which expires in October 2013. The product is distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. There is a potential that Abbott's third-party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in this specific lot. This is classified as an FDA Class II recall.
Healthcare providers and patients should discontinue use of the affected lot and contact Abbott Laboratories for further instructions or replacement.
The recalled product
- Product
- ZEMPLAR (PARICALCITOL)
- Brand
- ZEMPLAR
- Manufacturer
- Abbott Laboratories
- Category
- Drug — Injectable
- Affected units
- 121,000
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 #: 11-122-DK
- Exp 10/13
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ZEMPLAR
- LowAbbVie Recalls Zemplar Capsules for Failed Content Uniformity Specifications
FDA (Drugs) · 2016-04-27
Same manufacturer · Abbott Laboratories
See all →- HighChemistry analyzer control modules recalled over software that may give erroneous results
FDA (Devices) · 2025-12-24
- HighHematology analyzers recalled because saturation flags may not be applied
FDA (Devices) · 2025-11-19
- HighCELL-DYN Ruby hematology analyzer system expiration date validation
FDA (Devices) · 2025-04-30
- HighCELL-DYN Ruby Hematology Analyzer Expiration Date Software Defect
FDA (Devices) · 2025-04-30
- HighCELL-DYN Ruby hematology analyzer expiration date software defect
FDA (Devices) · 2025-04-30
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- LowAbbVie Recalls Zemplar Capsules for Failed Content Uniformity Specifications
FDA (Drugs) · 2016-04-27
- SevereShilpa Medicare Recalls Azacitidine Injection Due to Manufacturing Deviations
FDA (Drugs) · 2020-12-16
- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Vancomycin Injection Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereCipla Recalls Azacitidine Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2020-12-23
- ModerateAmpicillin for Injection Recalled Due to Foreign Object Contamination
FDA (Drugs) · 2022-10-05