Boehringer Ingelheim Roxane Recalls Calcitriol Oral Solution Due to Impurity
Boehringer Ingelheim Roxane Inc. is recalling 5,364 bottles of Calcitriol Oral Solution 1 mcg/mL due to a failed impurity specification.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, an FDA Class II recall with potential for adverse health consequences (implied by the impurity failure) maps to a severity score of 4 (Severe), as it is not Class I (Critical) but involves a significant quality failure.
Plain-English summary
Boehringer Ingelheim Roxane Inc. is recalling 5,364 bottles of Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only. The product is identified by NDC 0054-3120-41, Lot # 360122A, and an expiration date of MAY 2015. The recall was initiated because the product failed an impurity/degradation specification, specifically being out of specification for trans-calcitriol degradant at the 9-month stability time point.
The affected product was distributed nationwide. This is a prescription-only medication manufactured by Boehringer Ingelheim Roxane Inc. (Roxane Laboratories, Inc., Columbus, Ohio). The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Patients and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The recall is limited to the specific lot and expiration date listed above.
The recalled product
- Product
- CALCITRIOL (CALCITRIOL)
- Brand
- CALCITRIOL
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 5,364
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 360122A
- EXP Date: MAY 2015
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Boehringer Ingelheim Roxane Inc
See all →- ModerateBoehringer Ingelheim Roxane Recalls Furosemide Tablets Due to CGMP Deviations
FDA (Drugs) · 2015-10-21
- ModerateBoehringer Ingelheim Roxane Recalls Furosemide Tablets Due to Manufacturing Error
FDA (Drugs) · 2015-10-21
- ModerateBoehringer Ingelheim Recalls Defective Combivent Respimat Inhalers
FDA (Drugs) · 2015-08-05
- ModerateBoehringer Ingelheim Roxane Recalls Subpotent Acarbose Tablets
FDA (Drugs) · 2015-06-03
- LowOxycodone Hydrochloride Oral Solution Recalled for Stability Failure
FDA (Drugs) · 2014-08-06
Same hazard · impurity
See all →- ModerateAjanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2026-09-16
- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
Similar recalls
- ModerateBoehringer Ingelheim Recalls Perindopril Erbumine Tablets Due to Impurity
FDA (Drugs) · 2013-01-23
- LowOxycodone Hydrochloride Oral Solution Recalled for Stability Failure
FDA (Drugs) · 2014-08-06
- ModerateValidus Recalls Calcitriol Oral Solution Due to Subpotency
FDA (Drugs) · 2018-09-05
- LowValidus Recalls Rocaltrol Oral Solution Due to Lower Potency
FDA (Drugs) · 2018-09-05
- LowWest-Ward Recalls Oxycodone Hydrochloride Oral Solution for Impurity Failures
FDA (Drugs) · 2016-07-20
- ModerateBoehringer Ingelheim Recalls Oxcarbazepine Oral Suspension Due to Resuspension Issues
FDA (Drugs) · 2013-11-27