Rocaltrol — Class III drug recall D-1171-2018
Terminated recall by Validus Pharmaceuticals, Inc., reported 2018-09-05, distributed nationwide. Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
| Recall number | D-1171-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Validus Pharmaceuticals, Inc., Parsippany, NJ, United States |
| Recall initiated | 2018-06-15 |
| Classified | 2018-09-05 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2021-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 696 bottles |
| Reason classes | potency, specification failure |
| NDC | 30698-0911-15 |
| Expiration dates | 2019-09 |
Product
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
Reason for recall
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1171-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.