CLASS III Drug recall · Reported 5 Sep 2018 · FDA Enforcement Report
Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL recalled
Validus Pharmaceuticals is recalling Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, distributed nationwide in the US. The recall was initiated on 15 Jun 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1171-2018
- FDA event ID
- 80326
- Recalling firm
- Validus Pharmaceuticals, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Jun 2018
- FDA classified
- 5 Sep 2018
- Reported
- 5 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 15 Jun 2018 | Recall initiated by company | |
| 5 Sep 2018 | Classified by FDA | +82 days |
| 5 Sep 2018 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
U.S. nationwide
Questions about this recall
Why was it recalled?
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Which lots are affected?
RV1604, Exp 09/2019
Where was it sold?
U.S. nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 80326| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Calcitriol Oral Solution, 1 mcg/mL recalled by Validus Pharmaceuticals | Validus Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Validus Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Calcitriol Oral Solution, 1 mcg/mL recalled by Validus Pharmaceuticals | Validus Pharmaceuticals | Potency & Assay | Nationwide |