Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures
Teva Pharmaceuticals is recalling specific lots of Paricalcitol Capsules because stability testing revealed out-of-specification impurities.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Teva Pharmaceuticals USA is recalling 5,398 bottles of Paricalcitol Capsules, 4 mcg, 30-count bottles. The product is prescription-only and was distributed nationwide and in Puerto Rico. The recall involves Lot # 13010.006A (Exp 09/16) and Lot # 13010.007A (Exp 05/17).
The recall was initiated because the product failed impurities and degradation specifications. Specifically, stability testing resulted in out-of-specification test results for impurities. The FDA has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
Healthcare providers and patients should stop using the affected lots of Paricalcitol Capsules. Consumers should check their medication bottles for the specific lot numbers and expiration dates listed above. If the medication matches the recalled lots, it should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 5,398
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 (4)
- Lot #: 13010.006A
- Exp 09/16
- 13010.007A
- Exp 05/17
Distribution
Part of a larger recall action
This product is one of 3 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →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