Multi-event August 2026 FDA Recall Drug by Safecor Health, Llc
This Multi-event Class II drug recall was voluntarily initiated by Safecor Health, Llc on August 13, 2026 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0845-2026
Failed Stability Specifications
08-13-2026
09-23-2026
N/A
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.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
Batch or Lot Expiration Information
Lot# :26080483; Exp :03/13/2027
Lot# :25310327; Exp :08/12/2026
Lot# :25330414; Exp :08/26/2026
Lot# :25430340; Exp :11/22/2026
Recall Number: D-0846-2026
Failed Stability Specifications
08-13-2026
09-23-2026
N/A
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.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
Batch or Lot Expiration Information
Lot# :25330415; Exp :08/26/2026
Lot# :25340169; Exp :09/05/2026
Lot# :25380387; Exp :10/17/2026
Lot# :25410936; Exp :11/13/2026
Lot# :25450649; Exp :11/30/2026
Lot# :25471328; Exp :01/05/2027
Lot# :26120385; Exp :03/27/2027
Lot# :26141494; Exp :04/07/2027
Lot# :26170183; Exp :04/21/2027
Lot# :26220497; Exp :05/28/2027
Recall Number: D-0844-2026
Failed Stability Specifications
08-13-2026
09-23-2026
N/A
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.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
Batch or Lot Expiration Information
Lot# :25421159; Exp :10/21/2026
Lot# :25431644; Exp :11/03/2026
Lot# :25471687; Exp :12/02/2026
Lot# :25510930; Exp :01/05/2027
Lot# :26130247; Exp :04/17/2027
Lot# :25450648; Exp :11/30/2026
Lot# :26061716; Exp :02/28/2027
Lot# :26120384; Exp :03/27/2027
Lot# :26141493; Exp :04/07/2027
Lot# :26190055; Exp :05/04/2027
Lot# :26231530; Exp :06/05/2027
Recall Number: D-0841-2026
Failed Stability Specifications
08-13-2026
09-23-2026
N/A
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.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
Batch or Lot Expiration Information
Lot# 26160463; Exp :04/20/2027
Lot# 25430188; Exp :11/26/2026
Lot# 25440715; Exp :12/9/2026
Lot# 25501160; Exp :01/21/2027
Lot# 26021054; Exp :02/5/2027
Lot# 26130635; Exp :04/3/2027
Lot# 26200964; Exp :05/13/2027
Recall Number: D-0843-2026
Failed Stability Specifications
08-13-2026
09-23-2026
N/A
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.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
Batch or Lot Expiration Information
Lot# :26220866; Exp :06/18/2027
Lot# :25321477; Exp :0/18/2026
Lot# :25471651; Exp :12/01/2026
Lot# :25500133; Exp :12/19/2026
Lot# :26161398; Exp :12/31/2026
Lot# :26170946; Exp :05/15/2027
Lot# :26240033; Exp :05/31/2027
Recall Number: D-0842-2026
Failed Stability Specifications
08-13-2026
09-23-2026
N/A
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.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
Batch or Lot Expiration Information
Lot# :25330169; Exp :08/25/2026
Lot# :25340107; Exp :09/04/2026
Lot# :25370044; Exp :09/30/2026
Lot# :25391430; Exp :10/30/2026
Lot# :25411035; Exp :11/13/2026
Lot# :25461036; Exp :12/12/2026
Lot# :25450206; Exp :12/12/2026
Lot# :25521269; Exp :02/03/2027
Lot# :26030426; Exp :02/09/2027
Lot# :26071765; Exp :03/11/2027
Lot# :26111371; Exp :03/24/2027
Lot# :26121435; Exp :03/31/2027
Lot# :26141209; Exp :04/07/2027
Lot# :26151211; Exp :04/13/2027
Lot# :26170561; Exp :04/23/2027
Lot# :26171144; Exp :04/24/2027
Lot# :26191168; Exp :05/08/2027
Lot# :26210307; Exp :05/21/2027
Lot# :26231182; Exp :06/04/2027
Lot# :26241285; Exp :06/15/2027
