Drug recall: Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution…

Class II FDA enforcement event 96308. Recall start date: 17 Feb 2025. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Safecor Health, LLC started this drug recall on 17 Feb 2025. The firm address in the FDA record is in Columbus, OH. FDA put the recall in Class II. FDA event 96308 has 5 product records. The first FDA enforcement report date is 12 Mar 2025. The record gives the status Ongoing.

FDA enforcement report The 5 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA

Recalling firm

Safecor Health, LLC, Columbus, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

5 product records in the event.

FDA event 96308: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0250-2025	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, OH 43204, NDC: 69367028302.	3069 Oral Syringes	Class II	Ongoing	12 Mar 2025
D-0251-2025	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.	10992 Oral Syringes	Class II	Ongoing	12 Mar 2025
D-0252-2025	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) 39328055750, c) 69618007059.	1535 Oral Syringes	Class II	Ongoing	12 Mar 2025
D-0253-2025	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) 00054353244, b) 00121077001, c) 65162068784.	3465 Oral Syringes	Class II	Ongoing	12 Mar 2025
D-0254-2025	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) 00406800330, c) 00054051750.	12390 Oral Syringes	Class II	Ongoing	12 Mar 2025

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2025: 322
Share of these events in Class II: 79%
Product records in this event: 5Median of the firm: 1
Events of the firm on the register: 12

Other events of the firm

Other FDA enforcement events of Safecor Health, LLC
Initiated	Product (first record)	Type	Class	Records
13 Aug 2026	Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Onl	Drug	Class II	6
1 May 2026	Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 m	Drug	Class II	1
30 Apr 2026	Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:	Drug	Class II	1
10 Oct 2025	Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manuf	Drug	Class II	1
11 Nov 2024	Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01	Drug	Class II	5
19 Oct 2023	Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health	Drug	Class II	1
12 Sep 2016	Safecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-0108-01 Distributed by: SAFECOR HEALTH, 317 NEW BOSTON STREET,	Food	Class III	1
7 Jul 2016	Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.	Drug	Class II	6
13 Aug 2015	Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and on	Drug	Class II	1
16 Jul 2015	Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23	Drug	Class II	1

Safecor Health, LLC: all 12 events

Official channels

FDA enforcement report D-0250-2025The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 96308. https://recallregister.com/fda/ii/96308/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA
What quantity of product is in FDA event 96308?: The event has 5 product records. The first record gives this quantity: 3069 Oral Syringes
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2025 have the same class?: 79% of the 322 drug events that started in 2025 are in Class II.