Safecor Health recalls

Safecor Health appears in 30 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-23.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• 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:…
  FDA Drug · Class II · 2026-09-23 · Safecor Health
  Reason: Failed Stability Specifications
• Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:…
  FDA Drug · Class II · 2026-09-23 · Safecor Health
  Reason: Failed Stability Specifications
• 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, Pkg by:…
  FDA Drug · Class II · 2026-09-23 · Safecor Health
  Reason: Failed Stability Specifications
• 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, Pkg by:…
  FDA Drug · Class II · 2026-09-23 · Safecor Health
  Reason: Failed Stability Specifications
• 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:…
  FDA Drug · Class II · 2026-09-23 · Safecor Health
  Reason: Failed Stability Specifications
• Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:…
  FDA Drug · Class II · 2026-09-23 · Safecor Health
  Reason: Failed Stability Specifications
• Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe,…
  FDA Drug · Class II · 2026-05-27 · Safecor Health
  Reason: Presence of a Foreign Substance; black particles observed in liquid
• Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus,…
  FDA Drug · Class II · 2026-05-27 · Safecor Health
  Reason: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
• Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan…
  FDA Drug · Class II · 2025-12-10 · Safecor Health
  Reason: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
• Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health,…
  FDA Drug · Class II · 2025-03-12 · Safecor Health
  Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
• Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster,…
  FDA Drug · Class II · 2025-03-12 · Safecor Health
  Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
• Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Colu…
  FDA Drug · Class II · 2025-03-12 · Safecor Health
  Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
• Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, ND…
  FDA Drug · Class II · 2025-03-12 · Safecor Health
  Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
• Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus,…
  FDA Drug · Class II · 2025-03-12 · Safecor Health
  Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
• Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01
  FDA Drug · Class II · 2024-11-27 · Safecor Health
  Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
• Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01
  FDA Drug · Class II · 2024-11-27 · Safecor Health
  Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
• Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
  FDA Drug · Class II · 2024-11-27 · Safecor Health
  Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
• Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01
  FDA Drug · Class II · 2024-11-27 · Safecor Health
  Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
• Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
  FDA Drug · Class II · 2024-11-27 · Safecor Health
  Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
• Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 0…
  FDA Drug · Class II · 2023-11-08 · Safecor Health
  Reason: CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
• Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009
  FDA Drug · Class II · 2017-06-21 · Safecor Health
  Reason: CGMP Deviations
• Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402
  FDA Drug · Class II · 2017-06-21 · Safecor Health
  Reason: CGMP Deviations
• Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280
  FDA Drug · Class II · 2017-06-21 · Safecor Health
  Reason: CGMP Deviations
• Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305
  FDA Drug · Class II · 2017-06-21 · Safecor Health
  Reason: CGMP Deviations
• Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392
  FDA Drug · Class II · 2017-06-21 · Safecor Health
  Reason: CGMP Deviations
• Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205
  FDA Drug · Class II · 2017-06-21 · Safecor Health
  Reason: CGMP Deviations
• Safecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-0108-01 Distributed by: SAFECOR HEALTH, 317 NEW BOSTON STREET, WOBURN, MA
  FDA Food · Class III · 2016-12-14 · Safecor Health
  Reason: Box labeled Thiamine Hydrochloride instead of Thiamine Mononitrate
• Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG:…
  FDA Drug · Class II · 2016-04-06 · Safecor Health
  Reason: Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
• Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc
  FDA Drug · Class II · 2016-02-17 · Safecor Health
  Reason: Defective Container: Confirmed customer complaints of leaking bottles.
• Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box contain…
  FDA Drug · Class II · 2016-02-17 · Safecor Health
  Reason: Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.