Safecor Health Fluphenazine HCl Elixir Recall Over Failed Stability Specifications (Ref. ff1259)
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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.
It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.
Before acting, the primary agency source is available to check alongside this summary. 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 recall affects Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, packaged by Safecor Health, Woburn, MA 01801 with NDC 00121-0654-16. Affected lots include: Lot# 26220866 (Exp 06/18/2027), Lot# 25321477 (Exp 0/18/2026), Lot# 25471651 (Exp 12/01/2026), Lot# 25500133 (Exp 12/19/2026), Lot# 26161398 (Exp 12/31/2026), Lot# 26170946 (Exp 05/15/2027), Lot# 26240033 (Exp 05/31/2027). The recall is classified as Class II and distributed nationwide in the USA under recall number D-0843-2026.
What You Should Do
Consumers should contact Safecor Health, LLC for return or refund instructions regarding the affected product.
Why This Matters
The recall involves a prescription oral medication distributed nationwide that failed stability specifications.
Source
FDA recall number D-0843-2026
Original source: FDA Official Notice ↗
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Comparable nationwide notices (length or severity timing) 8
Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,062 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 29, 2026.
Questions & Answers
Common questions about this FDA recall.