CLASS I ONGOING Drug recall · Reported 24 Feb 2016 · FDA Enforcement Report
Vitamin Supplement (Vial) D3, (cholecalciferol recalled by Glades Drugs
Glades Drugs is recalling Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol, distributed in Georgia, New York. The recall was initiated on 6 Nov 2015 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0669-2016
- FDA event ID
- 72737
- Recalling firm
- Glades Drugs, Pahokee, FL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 6 Nov 2015
- FDA classified
- 16 Feb 2016
- Reported
- 24 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Nov 2015 | Recall initiated by company | |
| 16 Feb 2016 | Classified by FDA | +102 days |
| 24 Feb 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/choline bitartrate USP) capsules, 60, 120 or 180 count vials, Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.
Where it was distributed
New York and Georgia
Questions about this recall
Why was it recalled?
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Which lots are affected?
AICACABF@3, AICECABF@2, AJBFCABF@4, ABCCABF@4, AICACABF@5, AICECABF@3, AJBHCABF@2, ABCCABF@5, AICBCABF@1, AICECABF@4, AJCBCABF@1, ABGCABF@4, AICBCABF@2, AICECABF@5, JCBCABF@2, BACDCABF@5, AICBCABF@3, AICICABF@3, BAAGCABF@2, BADACABF@3, AICBCABF@4, AJADCABF@1, BAAICABF@1, BACCABF@3, AICECABF@1, AJBECABF@6, BABCCABF@2 and BBAECABF@5, Exp 02/20/2016
Where was it sold?
New York and Georgia
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.