Drug recall: Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and…

Class II FDA enforcement event 72970. Recall start date: 13 Aug 2015. Status in the FDA record: Terminated. Termination date: 25 Feb 2016.

Reason for recall, in the words of FDA

Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.

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 13 Aug 2015. The firm address in the FDA record is in Woburn, MA. FDA put the recall in Class II. FDA event 72970 has 1 product record. The first FDA enforcement report date is 17 Feb 2016. The record gives the status Terminated, with the termination date 25 Feb 2016.

FDA enforcement report The 1 product record

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.

NY

Recalling firm

Safecor Health, LLC, Woburn, MA.

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

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

Products

1 product record in the event.

FDA event 72970: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0657-2016	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 containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.	132 unit dose cups	Class II	Terminated	17 Feb 2016

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 2015: 292
Share of these events in Class II: 52%
Product records in this event: 1Median 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
17 Feb 2025	Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mf	Drug	Class II	5
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
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-0657-2016The 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 72970. https://recallregister.com/fda/ii/72970/. 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: NY
What quantity of product is in FDA event 72970?: The FDA record gives this quantity: 132 unit dose cups
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2015 have the same class?: 52% of the 292 drug events that started in 2015 are in Class II.