FDAClass II · Drug · Recall D-0842-2026 · Recalled September 23, 2026

Fluphenazine HCl Elixir recall — Safecor Health, LLC

Agency report date: September 23, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Fluphenazine HCl Elixir
Company / brand: Safecor Health
Lot / serial / date codes: Lot #:25330169; Exp :08/25/2026 Lot #:25340107; Exp :09/04/2026 Lot #:25370044; Exp :09/30/2026 Lot #:25391430; Exp :10/30/2026 Lot #:25411035; Exp :11/13/2026 Lot #:25461036; Exp :12/12/2026 Lot #:25450206; Exp :12/12/2026 Lot #:25521269; Exp :02/03/2027 Lot #:26030426; Exp :02/09/2027 Lot #:26071765; Exp :03/11/2027 Lot #:26111371; Exp :03/24/2027 Lot #:26121435; Exp :03/31/2027 Lot #:26141209; Exp :04/07/2027 Lot #:26151211; Exp :04/13/2027 Lot #:26170561; Exp :04/23/2027 Lot #:26171144; Exp :04/24/2027 Lot #:26191168; Exp :05/08/2027 Lot #:26210307; Exp :05/21/2027 Lot #:26231182; Exp :06/04/2027 Lot #:26241285; Exp :06/15/2027
Distribution: Nationwide in the USA.

Agency product description and boundaries

Fluphenazine HCl Elixir, USP, 5 mg per 1 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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Failed Stability Specifications

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Fluphenazine HCl Elixir recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0842-2026
Brand: All Safecor Health recalls
Classification: Class II
Units affected: N/A
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Fluphenazine HCl Elixir recall status

Companies & origin

Recalling firm location: Woburn, MA, United States
Firm address: 317 New Boston St, N/A, 01801-6231

Identifying details (verbatim from the notice)

Product codes / lots: Lot #:25330169; Exp :08/25/2026 Lot #:25340107; Exp :09/04/2026 Lot #:25370044; Exp :09/30/2026 Lot #:25391430; Exp :10/30/2026 Lot #:25411035; Exp :11/13/2026 Lot #:25461036; Exp :12/12/2026 Lot #:25450206; Exp :12/12/2026 Lot #:25521269; Exp :02/03/2027 Lot #:26030426; Exp :02/09/2027 Lot #:26071765; Exp :03/11/2027 Lot #:26111371; Exp :03/24/2027 Lot #:26121435; Exp :03/31/2027 Lot #:26141209; Exp :04/07/2027 Lot #:26151211; Exp :04/13/2027 Lot #:26170561; Exp :04/23/2027 Lot #:26171144; Exp :04/24/2027 Lot #:26191168; Exp :05/08/2027 Lot #:26210307; Exp :05/21/2027 Lot #:26231182; Exp :06/04/2027 Lot #:26241285; Exp :06/15/2027
Distribution: Nationwide in the USA.
Firm notified the public via: Letter
FDA event ID: 99654
Recall initiated: August 13, 2026
FDA classified: September 14, 2026
FDA report date: September 23, 2026

Other drug recalls from around the same time

Thyroid Tablets recall — VITRUVIAS THERAPEUTICS INCFDA · September 23, 2026
0 recall — B BRAUN MEDICAL INCFDA · September 16, 2026
Epinephrine Injection recall — American Regent, Inc.FDA · September 16, 2026
Dextrose Injection recall — Baxter Healthcare CorporationFDA · September 16, 2026
Glutathione 200 mg/mL recall — OPTIMAL BALANCE PHARMACYFDA · September 9, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

Report a data error on this page