The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0842-2026·Announced 2026-09-23

Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures

Safecor Health is recalling Fluphenazine HCl Elixir because it failed stability specifications. The product is distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving potential quality issues.

Plain-English summary

Safecor Health, LLC is recalling Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, 10 mL oral elixir. The recall was initiated because the product failed stability specifications.

The affected product is distributed nationwide in the USA. The recall includes multiple lots with expiration dates ranging from August 2026 to June 2027.

Consumers should check their inventory for the specific NDC 00121-0653-04 and lot numbers listed in the official recall notice. If the product is found, it should be returned to the pharmacy or point of purchase for disposal or replacement.

The recalled product

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
Manufacturer
Safecor Health, LLC
Category
Drug — Antipsychotic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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