Why it was recalled
Failed Stability Specifications
Product description
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
Lot numbers, UPCs & expiration codes
Lot#26160463; Exp :04/20/2027 Lot#25430188; Exp :11/26/2026 Lot#25440715; Exp :12/9/2026 Lot#25501160; Exp :01/21/2027 Lot#26021054; Exp :02/5/2027 Lot#26130635; Exp :04/3/2027 Lot#26200964; Exp :05/13/2027
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0841-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 13, 2026
- FDA report date
- Sep 23, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Safecor Health, LLC
Original FDA data
Every field from FDA enforcement report D-0841-2026, exactly as published.
Show all FDA fields
- City
- Woburn
- State
- MA
- Status
- Ongoing
- Country
- United States
- Event ID
- 99654
- Address
- 317 New Boston St
- Code information
- Lot#26160463; Exp :04/20/2027 Lot#25430188; Exp :11/26/2026 Lot#25440715; Exp :12/9/2026 Lot#25501160; Exp :01/21/2027 Lot#26021054; Exp :02/5/2027 Lot#26130635; Exp :04/3/2027 Lot#26200964; Exp :05/13/2027
- Postal code
- 01801-6231
- Report date
- Sep 23, 2026
- Product type
- Drugs
- Recall number
- D-0841-2026
- Classification
- Class II
- Recalling firm
- Safecor Health, LLC
- Reason for recall
- Failed Stability Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Aug 13, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 14, 2026