CLASS II Drug recall · Reported 17 Feb 2016 · FDA Enforcement Report

Midazolam HCl Syrup, 10 mg/ unit dose cups recalled by Safecor Health

Safecor Health is recalling Midazolam HCl Syrup, 10 mg/ unit dose cups, distributed in New York. The recall was initiated on 13 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 932333, Exp 08/04/16

Quantity recalled132 unit dose cups

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0657-2016
FDA event ID: 72970
Recalling firm: Safecor Health, Woburn, MA
Classification: Class II
Status: Terminated
Recall initiated: 13 Aug 2015
FDA classified: 10 Feb 2016
Reported: 17 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects

Timeline

13 Aug 2015	Recall initiated by company
10 Feb 2016	Classified by FDA	+181 days
17 Feb 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

New York

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot: 932333, Exp 08/04/16

Where was it sold?

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Safecor Health

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27 May 2026Drug	CLASS II	Vitamin B-Complex, Vitamin C & Folic Acid Dietary recalled	Safecor Health	Particulate Matter	OH
27 May 2026Drug	CLASS II	Atomoxetine Capsules HCL in unit dose foil strip, strips recalledAtomoxetine	Safecor Health	Labeling Errors	TX
10 Dec 2025Drug	CLASS II	Haloperidol Lactate Injection, 5 mg/mL recalled by Safecor HealthHaloperidol Lactate	Safecor Health	Packaging Defects	MA
12 Mar 2025Drug	CLASS II	Simethicone 20 mg per Oral Syringe, Delivers:, Oral Drops recalled	Safecor Health	Packaging Defects	Nationwide
12 Mar 2025Drug	CLASS II	Morphine Sulfate 5 mg per Oral Syringe, Delivers:, Oral Solution recalled	Safecor Health	Packaging Defects	Nationwide

Other Midazolam recalls

All 36

Reported	Class	Recall	Company	Reason	Where
3 Apr 2024Drug	CLASS II	Midazolam HCl 100 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Midazolam in 0.8% Sodium Chloride Injection 100 mg recalled	Exela Pharma Sciences	Particulate Matter	Nationwide
11 Oct 2023Drug	CLASS II	midazolam in dextrose 5%, 50 mg/, (1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	midazolam in dextrose 5%, 50 mg /, (1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
7 Jun 2023Drug	CLASS II	Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn	Akorn	Potency & Assay	Nationwide