Teva PARICALCITOL Capsules Recall: Impurities Risk
Teva Pharmaceuticals USA recalls PARICALC: 2 mcg capsules due to impurities in stability testing. This may affect safety for patients using prescription calcium supplements.
Lower-risk recall
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Contact the company
What happened, in plain English
Teva Pharmaceuticals USA is recalling PARICALCITOL capsules (2 mcg, 30-count) because impurities were found during stability testing. This could pose a safety risk for patients using these prescription calcium supplements. Read more at govinfonow.com/recall/42321-teva-paricalcitol-capsules-recall-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42321-teva-paricalcitol-capsules-recall-impurities-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0110-2017
Cite this page
“Teva PARICALCITOL Capsules Recall: Impurities Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42321-teva-paricalcitol-capsules-recall-impurities-risk. Based on FDA recall #D-0110-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0110-2017%22&limit=1).
Why it’s dangerous
The capsules failed stability testing for impurities, which could lead to unsafe levels of substances in the product. This might affect how the medication works or cause side effects in patients using it.
Who’s affected
Patients prescribed PARICALCITOL capsules by a doctor. Those with kidney issues or on calcium supplements are most at risk.
How to tell if you have this one
Check for PARICALCITOL capsules labeled 2 mcg, 30-count, manufactured by Pharmaceutics International, Inc., Hunt, MD. The lot number 13016.011A with expiration 03/17 is affected.
- Brand
Teva Pharmaceuticals USA- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0109-2017 | PARICALCITOL Capsules, 1 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 0093-7656-56.; Lot #: 13013.013A, Exp 04/17 | 32,015 bottles |
| D-0110-2017 | PARICALCITOL Capsules, 2 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 0093-7657-56.; Lot #: 13016.011A, Exp 03/17 | 5,556 bottles |
| D-0111-2017 | 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.; Lot #: 13010.006A, Exp 09/16; 13010.007A, Exp 05/17 | 5,398 bottles |
What to do — step by step
Check Product Details
Look for the product name, strength (2 mcg), count (30), and lot number 13016.011A on the capsule packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0110-2017 (September 22, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0110-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.