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Safecor Health, LLC recall records

19 reported ongoing

20 records in this archive. Latest source date Aug 13, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

Aug 13, 2026FDA drug enforcement

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...

Failed Stability Specifications

Class IIReported ongoing

Distribution: Nationwide in the USA.

Official source

Aug 13, 2026FDA drug enforcement

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:...

Failed Stability Specifications

Class IIReported ongoing

Distribution: Nationwide in the USA.

Official source

Aug 13, 2026FDA drug enforcement

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: Safecor Health, Woburn, MA 01801. NDC...

Failed Stability Specifications

Class IIReported ongoing

Distribution: Nationwide in the USA.

Official source

Aug 13, 2026FDA drug enforcement

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: Safecor Health, Woburn, MA 01801. NDC...

Failed Stability Specifications

Class IIReported ongoing

Distribution: Nationwide in the USA.

Official source

Aug 13, 2026FDA drug enforcement

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: Safecor Health, Woburn, MA 01801. NDC...

Failed Stability Specifications

Class IIReported ongoing

Distribution: Nationwide in the USA.

Official source

Aug 13, 2026FDA drug enforcement

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: Safecor Health, Woburn, MA 01801. NDC...

Failed Stability Specifications

Class IIReported ongoing

Distribution: Nationwide in the USA.

Official source

May 1, 2026FDA drug enforcement

Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by:...

Presence of a Foreign Substance; black particles observed in liquid

Class IIReported ongoing

Distribution: OH

Official source

Apr 30, 2026FDA drug enforcement

Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

Class IIReported ongoing

Distribution: TX only

Official source

Oct 10, 2025FDA drug enforcement

Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 2660...

Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

Class IIReported ongoing

Distribution: Distributed in Massachusetts

Official source

Feb 17, 2025FDA drug enforcement

Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus,...

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Feb 17, 2025FDA drug enforcement

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, NDC: 00536130375.

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Feb 17, 2025FDA drug enforcement

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, OH 43204. NDC: a) 71399748005, b) 3932...

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Feb 17, 2025FDA drug enforcement

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, LLC, Columbus, OH 43204, NDC: a) 00054...

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Feb 17, 2025FDA drug enforcement

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, Columbus, OH 43204, NDC: a) 00406800312, b...

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Nov 11, 2024FDA drug enforcement

Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Class IIReported ongoing

Distribution: USA nationwide.

Official source

Nov 11, 2024FDA drug enforcement

Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Class IIReported ongoing

Distribution: USA nationwide.

Official source

Nov 11, 2024FDA drug enforcement

Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Class IIReported ongoing

Distribution: USA nationwide.

Official source

Nov 11, 2024FDA drug enforcement

Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Class IIReported ongoing

Distribution: USA nationwide.

Official source

Nov 11, 2024FDA drug enforcement

Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Class IIReported ongoing

Distribution: USA nationwide.

Official source

Oct 19, 2023FDA drug enforcement

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 01801. NDC# 48433-230-15

CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.

Class IIReported terminated

Distribution: Distributed Nationwide in the USA

Official source

Reasons in these listed records

Failed Stability Specifications
Presence of a Foreign Substance; black particles observed in liquid
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

These examples come from this result page and are not a ranking of every recall reason.

Checking Safecor Health, LLC

Is there a recall on safecor health, llc right now?

This archive contains 20 records, including 19 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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