Calcitriol Oral Solution (Validus) – Subpotency Issue (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
Brand
Validus Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
RV1602RB, Exp 07/2019, RV1604RB, Exp 9/2019, RV1605RB, Exp 10/2019
Products Sold
RV1602RB, Exp 07/2019; RV1604RB, Exp 9/2019; RV1605RB, Exp 10/2019
Validus Pharmaceuticals, Inc. is recalling Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals I due to Subpotency: lower than expected potency result was obtained at the 18 month stability time point.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026