Multi-event November 2024 FDA Recall Calcium Antacid by Safecor Health, Llc
This Multi-event Class II drug recall was voluntarily initiated by Safecor Health, Llc on November 11, 2024 for the product Calcium Antacid. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0056-2025
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
11-11-2024
11-27-2024
7488 boxes
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Safecor Health, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
Batch or Lot Expiration Information
Lot# 24A0052, exp. date 05/01/2026; 24A0057, exp. date 05/13/2026; 24A0066, exp. date 05/31/2026; 24A0067, exp. date 06/04/2026; 24A0068, exp. date 06/17/2026; 24A0069, exp. date 06/19/2026 24A0075, exp. date 07/08/2026 24A0078, exp. date 07/12/2026
Recall Number: D-0057-2025
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
11-11-2024
11-27-2024
3139 boxes
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Safecor Health, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01
Batch or Lot Expiration Information
Lot# 24A0050, exp. date 04/25/2026; 24A0055, exp. date 05/09/2026; 24A0059, exp. date 05/16/2026; 24A0060, exp. date 05/20/2026; 24A0071, exp. date 06/24/2026; 24A0072, exp. date 06/26/2026
Recall Number: D-0060-2025
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
11-11-2024
11-27-2024
587 boxes
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Safecor Health, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
Batch or Lot Expiration Information
Lot# 34A0054, exp. date 05/07/2026
Recall Number: D-0058-2025
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
11-11-2024
11-27-2024
1470 boxes
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Safecor Health, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01
Batch or Lot Expiration Information
Lot# 24A0061, exp. date 05/23/2026
Affected Packages Involved in this Recall
Recall Number: D-0059-2025
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
11-11-2024
11-27-2024
791 boxes
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Safecor Health, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01
Batch or Lot Expiration Information
Lot# 24A0073, exp. date 06/28/2026
