Class II · Moderate risk
Calcitriol Injection 2 mcg/mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Is Calcitriol recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Calcitriol (9 total). Check the affected lots below.
Most common reason: Labeling / mix-up (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Calcitriol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Calcitriol recalls on record
none so far in 2026; 9 on record, newest first
Class II · Moderate risk
Calcitriol Injection 1 mcg/mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Rocaltrol (calcitriol)
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class III · Low risk
Calcitriol Oral Solution
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class II · Moderate risk
Calcitriol active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Calcitriol Oral Solution 1 mcg/mL
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Class II · Moderate risk
Calcitriol
Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following drugs: ANAGRELIDE HCL, Capsule, 0.5 mg, NDC 00172524160, Pedigree: AD46414_7, EXP: 5/16/2014; BENAZEPRIL HCL, Tablet, 5 mg, NDC 65162075110, Pedigree: AD52778_7, EXP: 5/20/2014; CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003615, EXP: 6/25/2014.
Class II · Moderate risk
CALCITRIOL Capsule
Labeling:Label Mixup; CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, Tablet, 250 mg, NDC 10939043533, Pedigree: W003756, EXP: 5/31/2014; ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_28, EXP: 5/13/2014.
Class II · Moderate risk
Vitamin D3 Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
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