Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures
Teva Pharmaceuticals is recalling Paricalcitol Capsules because stability testing revealed out-of-specification impurities. The recall covers 30,891 bottles distributed nationwide and in Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential health risks such as impurities, even if specific injury reports are not detailed in the provided text.
Plain-English summary
Teva Pharmaceuticals USA is recalling Paricalcitol Capsules, 1 mcg, 30 tablets per bottle (NDC 0093-7656-56). The recall was initiated because stability testing produced out-of-specification results for impurities. The affected product is Lot # 13013.009A with an expiration date of 02/2016.
A total of 30,891 bottles were distributed nationwide and in Puerto Rico. The product was manufactured by Pharmaceutics International, Inc., and manufactured for Teva Pharmaceuticals USA. This is a prescription-only medication.
The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternatives or returns.
The recalled product
- Product
- Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 30,891
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 #: 13013.009A
- Exp. 02/2016
Distribution
Related recalls
Same manufacturer · Teva Pharmaceuticals USA
See all →- ModerateDoxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
- LowPrescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
- ModerateTretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
- LowMimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
- ModerateBrinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26
Same hazard · impurities
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMethohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide
FDA (Drugs) · 2026-07-15
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08