Safecor Health Fluphenazine HCl Elixir Recall Over Failed Stability Specifications (Aug 13, 2026, 00:00 UTC)
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Safecor Health, LLC is recalling multiple lots of Fluphenazine HCl Elixir, USP after the product failed stability specifications.
Reading this FDA recall beyond the headline
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, USP due to failed stability specifications.
Which Products Are Affected
The recall covers 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, packaged by Safecor Health, Woburn, MA 01801, NDC 00121-0653-04. Affected lots include: 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). The recall is classified as Class II and distributed nationwide in the USA under recall number D-0844-2026.
What You Should Do
Consumers should contact Safecor Health, LLC regarding the recalled product.
Why This Matters
The recall affects a prescription oral elixir distributed nationwide due to stability specification failures.
Source
FDA recall D-0844-2026, report date 20260923.
Original source: FDA Official Notice ↗
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