Validus Pharmaceuticals, Inc. recalls Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC
Validus Pharmaceuticals recalls Rocaltrol oral solution due to lower potency than expected at 18 months. This may affect medication effectiveness. Contact for details.
Lower-risk recall
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Contact the company & request your remedy
What happened, in plain English
Validus Pharmaceuticals is recalling Rocalt: a calcitriol oral solution that may have lower potency than expected after 18 months. This could mean the medication isn't as effective as it should be for patients needing it. Read more at govinfonow.com/recall/40436-validus-rocaltrol-oral-solution-recall-subpotency-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40436-validus-rocaltrol-oral-solution-recall-subpotency-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1171-2018
Cite this page
“Validus Rocaltrol Oral Solution Recall: Subpotency Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40436-validus-rocaltrol-oral-solution-recall-subpotency-risk. Based on FDA recall #D-1171-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1171-2018%22&limit=1).
Why it’s dangerous
The product may have lower potency than expected after 18 months of storage. This means the medication might not work as well for patients who need it.
Who’s affected
Patients prescribed Rocaltrol (calcitriol) oral solution by a doctor. Those with conditions requiring vitamin D treatment are most at risk.
How to tell if you have this one
Check for the 15 mL bottle labeled 'Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL'. The product was distributed by Validus Pharmaceuticals, LLC in Parsippany, NJ with NDC 30698-911-15.
- Brand
Validus Pharmaceuticals- Category
Drug
All 2 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
U.S. nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1170-2018 | Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59; RV1602RB, Exp 07/2019; RV1604RB, Exp 9/2019; RV1605RB, Exp 10/2019 | 7864 bottles | 63304-239-30, 63304-239-01, 63304-240-01, 63304-241-59 |
| D-1171-2018 | Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15; RV1604, Exp 09/2019 | 696 bottles | — |
What to do — step by step
Check Medication Details
Look for the 15 mL bottle labeled 'Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL' with NDC 30698-911-15.
Questions people ask
Is this product safe to use?
The product may have lower potency than expected after 18 months, but it is not unsafe. Patients should consult their doctor about medication effectiveness.
How do I know if I have the recalled product?
Check for the 15 mL bottle labeled 'Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL' with NDC 30698-911-15.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact your doctor or Validus Pharmaceuticals for guidance.
Contact Validus Pharmaceuticals
We’ve drafted a message you can send Validus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1171-2018 — Validus Pharmaceuticals Validus Pharmaceuticals Hello, I own a Validus Pharmaceuticals that is covered by recall D-1171-2018 from Validus Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1171-2018 (June 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1171-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.