Safecor Health Fluphenazine HCl Elixir Recall Over Failed Stability Specifications (Aug 13, 2026)
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Safecor Health, LLC is recalling multiple lots of Fluphenazine HCl Elixir, USP after the product failed stability specifications. The Class II recall affects products distributed nationwide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 29, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Failed Stability Specifications", distributed nationwide in the usa.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Safecor Health, LLC initiated a voluntary recall of Fluphenazine HCl Elixir because the product failed stability specifications.
Which Products Are Affected
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. Affected lots include: 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. Distribution was nationwide in the USA. Product quantity is listed as N/A.
What You Should Do
Consumers should check lot numbers on any Fluphenazine HCl Elixir products in their possession against the listed lots and contact the recalling firm for further guidance.
Why This Matters
This is a Class II recall involving a prescription oral elixir distributed nationwide.
Source
FDA recall number D-0846-2026, Safecor Health, LLC, Woburn, MA.
Original source: FDA Official Notice ↗
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