Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures

Plain-English summary

Safecor Health, LLC is recalling specific lots of Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL. The recall was initiated because the product failed stability specifications. The affected product is an oral elixir containing 14% alcohol by volume and is labeled for oral use only.

The recall covers seven specific lots with expiration dates ranging from November 2026 to May 2027. The affected lots were distributed nationwide in the United States. The FDA has classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be discontinued and returned to the distributor or manufacturer. Patients should consult their healthcare provider for alternative treatment options if they are currently using this medication.

The recalled product

Product

Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16

Manufacturer

Safecor Health, LLC

Category

Drug — Antipsychotic

Hazard

• stability-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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