Reported Sep 23, 2026 · Ongoing

Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use…

Safecor Health, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Safecor Health, LLC · 317 New Boston St · Woburn, MA · 01801-6231

Is this the product you have?

  • Fluphenazine HCl Elixir, USP, 5 mg per 1 mL
  • Delivers10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only
  • Pkg bySafecor Health, Woburn, MA 01801
  • NDC00121-0653-04
Lot codes and dates

21 of 21 products

Products covered by this recall
#Product as published
1Lot #:25330169
2Exp :08/25/2026 Lot #:25340107
3Exp :09/04/2026 Lot #:25370044
4Exp :09/30/2026 Lot #:25391430
5Exp :10/30/2026 Lot #:25411035
6Exp :11/13/2026 Lot #:25461036
7Exp :12/12/2026 Lot #:25450206
8Exp :12/12/2026 Lot #:25521269
9Exp :02/03/2027 Lot #:26030426
10Exp :02/09/2027 Lot #:26071765
11Exp :03/11/2027 Lot #:26111371
12Exp :03/24/2027 Lot #:26121435
13Exp :03/31/2027 Lot #:26141209
14Exp :04/07/2027 Lot #:26151211
15Exp :04/13/2027 Lot #:26170561
16Exp :04/23/2027 Lot #:26171144
17Exp :04/24/2027 Lot #:26191168
18Exp :05/08/2027 Lot #:26210307
19Exp :05/21/2027 Lot #:26231182
20Exp :06/04/2027 Lot #:26241285

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 3:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.