Validus Pharmaceuticals Calcitriol Oral Solution Recall

Why it was recalled

Subpotency: lower than expected potency result was obtained at the 18 month stability time point.

Product description

Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59

Lot numbers, UPCs & expiration codes

RV1602RB, Exp 07/2019; RV1604RB, Exp 9/2019; RV1605RB, Exp 10/2019

Where it was sold

U.S. nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1170-2018
Classification: Class III
Status: Terminated
Recall initiated: Jun 15, 2018
FDA report date: Sep 5, 2018
Quantity: 7864 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Validus Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-1170-2018, exactly as published.

Show all FDA fields

City: Parsippany
State: NJ
Status: Terminated
Country: United States
Event ID: 80326
Address: 119 Cherry Hill Rd Ste 310
Code information: RV1602RB, Exp 07/2019; RV1604RB, Exp 9/2019; RV1605RB, Exp 10/2019
Postal code: 07054-1126
Report date: Sep 5, 2018
Product type: Drugs
Recall number: D-1170-2018
Classification: Class III
Recalling firm: Validus Pharmaceuticals, Inc.
Product quantity: 7864 bottles
Termination date: Jan 22, 2021
Reason for recall: Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
Distribution pattern: U.S. nationwide
Recall initiation date: Jun 15, 2018
Initial firm notification: Letter
Center classification date: Sep 5, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1170-2018, published Sep 5, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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