Multi-event April 2025 FDA Recall Benlysta by Mckesson Medical-surgical Inc. Corporate Office
This Multi-event Class II drug recall was voluntarily initiated by Mckesson Medical-surgical Inc. Corporate Office on April 21, 2025 for the product Benlysta. The FDA reported the reason for recall as cgmp deviations; potential temperature excursions due to transit delays. The product was distributed in Within the U.S - OH, VA, FL. and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0539-2025
CGMP Deviations; potential temperature excursions due to transit delays
04-21-2025
07-30-2025
2 Pre-filled syringes
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.
Mckesson Medical-Surgical Inc. Corporate Office
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.
Within the U.S - OH, VA, FL.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
Batch or Lot Expiration Information
Lot# Lot: 1178382, Expiration date: 3/31/2027
Affected Packages Involved in this Recall
Recall Number: D-0540-2025
CGMP Deviations; potential temperature excursions due to transit delays
04-21-2025
07-30-2025
3 Vials
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.
Mckesson Medical-Surgical Inc. Corporate Office
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.
Within the U.S - OH, VA, FL.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Batch or Lot Expiration Information
Lot# Lot: YK4W, Expiration date: 4/30/2029
Affected Packages Involved in this Recall
Recall Number: D-0538-2025
CGMP Deviations; potential temperature excursions due to transit delays
04-21-2025
07-30-2025
6 Pre-filled syringes
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.
Mckesson Medical-Surgical Inc. Corporate Office
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.
Within the U.S - OH, VA, FL.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Batch or Lot Expiration Information
Lot# Lot: 1180924, Expiration date: 6/30/2027.
