Safecor Health Fluphenazine HCl Elixir Recall Over Failed Stability Specifications
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Safecor Health, LLC is recalling multiple lots of Fluphenazine HCl Elixir due to failed stability specifications.
The full picture behind this FDA recall
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 after the product failed stability specifications.
Which Products Are Affected
The affected product is 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, packaged by Safecor Health, Woburn, MA 01801, NDC 00121-0653-04. Affected lots include: Lot# 26080483 (Exp: 03/13/2027), Lot# 25310327 (Exp: 08/12/2026), Lot# 25330414 (Exp: 08/26/2026), and Lot# 25430340 (Exp: 11/22/2026). The recall is classified as Class II and distributed nationwide in the USA under recall number D-0845-2026.
What You Should Do
Consumers and healthcare providers should check product lots against the recalled codes and contact the recalling firm or their pharmacist regarding the affected product.
Why This Matters
The recall affects a prescription oral medication distributed nationwide, potentially impacting patients relying on the product for treatment.
Source
FDA recall D-0845-2026 (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts)
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,130 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 29, 2026.
Frequently Asked Questions
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