Multi-event August 2025 FDA Recall Chlorpromazine Hydrochloride by Avkare
This Multi-event Class II drug recall was voluntarily initiated by Avkare on August 25, 2025 for the product Chlorpromazine Hydrochloride. The FDA reported the reason for recall as presence of a foreign substance.. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0644-2025
Presence of a foreign substance.
08-25-2025
09-17-2025
2003 cartons
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.
AvKARE
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.
E-Mail
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.
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
Batch or Lot Expiration Information
Lot# 47089, Exp 12/31/25; 47604, Exp 03/31/26
Affected Packages Involved in this Recall
Recall Number: D-0643-2025
Presence of a foreign substance.
08-25-2025
09-17-2025
1512 cartons
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.
AvKARE
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.
E-Mail
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.
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
Batch or Lot Expiration Information
Lot# 46824, Exp 9/30/25; 47171, Exp 12/31/25
