Medications & Supplements/Prescription Drugs

Safecor Health Oral Medications Recalled for Leaking Syringes

Agency Publication Date: March 5, 2025

Summary

Safecor Health, LLC has recalled 31,451 oral solution syringes due to a defect that causes the delivery system to leak. The recall affects several medications, including Vitamin D (ergocalciferol), Simethicone drops, Iron supplement (ferrous sulfate), Lorazepam concentrate, and Morphine Sulfate solution. These products were repackaged into unit-dose syringes that were found to leak, potentially resulting in patients receiving incorrect or incomplete dosages of their medication.

Risk

The defective delivery system allows the oral liquid to leak from the syringe. This failure creates a risk of inaccurate dosing, which is particularly dangerous for powerful medications like Morphine and Lorazepam, where precise measurement is essential for safety and efficacy.

What You Should Do

This recall affects Vitamin D (ergocalciferol), Simethicone, Ferrous Sulfate, Lorazepam, and Morphine Sulfate oral syringes repackaged by Safecor Health, LLC (Columbus, OH).
Check your medications for the Safecor Health label and identify the specific lot numbers and expiration dates printed on the syringe packaging. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Ergocalciferol - Vitamin D Supplement (10 mcg/0.05 mL)

Variants: 10 mcg (400 Units) per 0.05 mL, Oral Solution

Lot Numbers:

24300812 (Exp 01/31/2025)

24530836 (Exp 07/19/2025)

NDC:

69367028302

Manufactured by Westminster, Packaged by Safecor Health, LLC.

Product: Simethicone Oral Drops (20 mg/0.3 mL)

Variants: 20 mg per 0.3 mL, Oral Drops

Lot Numbers:

24201295 (Exp 02/05/2025)

24210364 (Exp 02/20/2025)

24231720 (Exp 02/27/2025)

24500770 (Exp 06/26/2025)

24471182 (Exp 06/20/2025)

25031031 (Exp 07/22/2025)

NDC:

00536130375

Manufactured by Rugby, Packaged by Safecor Health, LLC.

Product: Ferrous Sulfate Iron Supplement Drops (7.5 mg Iron/0.5 mL)

Variants: 7.5 mg Iron/0.5 mL, Iron Supplement Drops

Lot Numbers:

24250093 (Exp 03/07/2025)

24321592 (Exp 04/04/2025)

24280320 (Exp 03/27/2025)

24371268 (Exp 04/19/2025)

24400519 (Exp 04/07/2025)

24500768 (Exp 06/24/2025)

25040972 (Exp 07/25/2025)

NDC:

71399748005

39328055750

69618007059

Manufactured by Akron Pharma, Packaged by Safecor.

Product: Lorazepam Oral Concentrate (0.5 mg/0.25 mL)

Variants: 0.5 mg per 0.25 mL, Oral Concentrate, Rx Only

Lot Numbers:

24210274 (Exp 01/31/2025)

24401700 (Exp 04/25/2025)

24251067 (Exp 03/25/2025)

24421733 (Exp 06/03/2025)

24261384 (Exp 03/24/2025)

24370127 (Exp 04/28/2025)

NDC:

00054353244

00121077001

65162068784

Manufactured by PAI, Packaged by Safecor Health, LLC.

Product: Morphine Sulfate Oral Solution (5 mg/0.25 mL)

Variants: 5 mg per 0.25 mL, Oral Solution, Rx Only

Lot Numbers:

24220672 (Exp 02/19/2025)

24280145 (Exp 03/18/2025)

24240711 (Exp 03/19/2025)

24180729 (Exp 01/23/2025)

25030427 (Exp 07/17/2025)

24360865 (Exp 03/31/2025)

24360864 (Exp 03/31/2025)

24480235 (Exp 06/21/2025)

NDC:

00406800312

00406800330

00054051750

Manufactured by Hikma, Packaged by Safecor Health, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96308

Status: Active

Manufacturer: Safecor Health, LLC

Sold By: Pharmacies; Hospitals; Healthcare Facilities

Manufactured In: United States

Units Affected: 5 products (3069 Oral Syringes; 10992 Oral Syringes; 1535 Oral Syringes; 3465 Oral Syringes; 12390 Oral Syringes)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Vitamin D (ergocalciferol), Simethicone, Ferrous Sulfate, Lorazepam, and Morphine Sulfate oral syringes repackaged by Safecor Health, LLC (Columbus, OH).

Check your medications for the Safecor Health label and identify the specific lot numbers and expiration dates printed on the syringe packaging. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Ergocalciferol - Vitamin D Supplement (10 mcg/0.05 mL)

Variants: 10 mcg (400 Units) per 0.05 mL, Oral Solution

Lot Numbers:

24300812 (Exp 01/31/2025)

24530836 (Exp 07/19/2025)

NDC:

69367028302

Manufactured by Westminster, Packaged by Safecor Health, LLC.

Product: Simethicone Oral Drops (20 mg/0.3 mL)

Variants: 20 mg per 0.3 mL, Oral Drops

Lot Numbers:

24201295 (Exp 02/05/2025)

24210364 (Exp 02/20/2025)

24231720 (Exp 02/27/2025)

24500770 (Exp 06/26/2025)

24471182 (Exp 06/20/2025)

25031031 (Exp 07/22/2025)

NDC:

00536130375

Manufactured by Rugby, Packaged by Safecor Health, LLC.

Product: Ferrous Sulfate Iron Supplement Drops (7.5 mg Iron/0.5 mL)

Variants: 7.5 mg Iron/0.5 mL, Iron Supplement Drops

Lot Numbers:

24250093 (Exp 03/07/2025)

24321592 (Exp 04/04/2025)

24280320 (Exp 03/27/2025)

24371268 (Exp 04/19/2025)

24400519 (Exp 04/07/2025)

24500768 (Exp 06/24/2025)

25040972 (Exp 07/25/2025)

NDC:

71399748005

39328055750

69618007059

Manufactured by Akron Pharma, Packaged by Safecor.

Product: Lorazepam Oral Concentrate (0.5 mg/0.25 mL)

Variants: 0.5 mg per 0.25 mL, Oral Concentrate, Rx Only

Lot Numbers:

24210274 (Exp 01/31/2025)

24401700 (Exp 04/25/2025)

24251067 (Exp 03/25/2025)

24421733 (Exp 06/03/2025)

24261384 (Exp 03/24/2025)

24370127 (Exp 04/28/2025)

NDC:

00054353244

00121077001

65162068784

Manufactured by PAI, Packaged by Safecor Health, LLC.

Product: Morphine Sulfate Oral Solution (5 mg/0.25 mL)

Variants: 5 mg per 0.25 mL, Oral Solution, Rx Only

Lot Numbers:

24220672 (Exp 02/19/2025)

24280145 (Exp 03/18/2025)

24240711 (Exp 03/19/2025)

24180729 (Exp 01/23/2025)

25030427 (Exp 07/17/2025)

24360865 (Exp 03/31/2025)

24360864 (Exp 03/31/2025)

24480235 (Exp 06/21/2025)

NDC:

00406800312

00406800330

00054051750

Manufactured by Hikma, Packaged by Safecor Health, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96308

Status: Active

Manufacturer: Safecor Health, LLC

Sold By: Pharmacies; Hospitals; Healthcare Facilities

Manufactured In: United States

Units Affected: 5 products (3069 Oral Syringes; 10992 Oral Syringes; 1535 Oral Syringes; 3465 Oral Syringes; 12390 Oral Syringes)

Distributed To: Nationwide