FDA Recall D-0059-2025
Safecor Health, LLC · Woburn, MA
Class II Ongoing 549 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01
Reason for recall
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Recall record
- Recall number
D-0059-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA nationwide.
- Recall initiated
- 2024-11-11
- Classified by FDA Center
- 2024-11-19
- FDA published
- 2024-11-27
- Recalling firm
- Safecor Health, LLC
- Firm location
- Woburn, MA
Drug identification
- Brand name(s)
- CALCIUM ANTACID
- Generic name(s)
- CALCIUM CARBONATE
- Manufacturer(s)
- Safecor Health, LLC
- NDC(s)
48433-106- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.