CLASS II Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report

Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg recalled

Nephron Sterile Compounding Center is recalling Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/ (1 mg/mL) Single-Dose Container, distributed nationwide in the US. The recall was initiated on 22 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: DS2053, Exp. 2/27/2023

Quantity recalled4,743 bottles

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-0355-2023
FDA event ID: 91749
Recalling firm: Nephron Sterile Compounding Center, West Columbia, SC
Classification: Class II
Status: Terminated
Recall initiated: 22 Feb 2023
FDA classified: 27 Feb 2023
Reported: 8 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Blood Pressure Medication

Timeline

22 Feb 2023	Recall initiated by company
27 Feb 2023	Classified by FDA	+5 days
8 Mar 2023	Published in enforcement report	+9 days

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

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lots: DS2053, Exp. 2/27/2023

Where was it sold?

Nationwide in the USA

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.

Other products in this recall event

7 other products · FDA event 91749

This product is part of a recall event; the main page for the event is Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled.

Reported	Class	Recall	Company	Reason	Where
8 Mar 2023	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023	CLASS II	Phenylephrine HCl Injection, USP, 1 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023	CLASS II	Phenylephrine HCl in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023	CLASS II	Phenylephrine HCl Injection, USP, 0.4 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023	CLASS II	Phenylephrine HCl Injection, USP, 0.8 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide

More recalls from Nephron Sterile Compounding Center

All 73

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025Drug	CLASS II	Sodium Chloride Injection 9%, USP, Single-Dose IV recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Phenylephrine HCl Injection, USP, 0.8 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Phenylephrine HCl Injection, USP, 0.4 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide

Other Diltiazem recalls

All 39

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules 12HR recalledDiltiazem Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg recalledDiltiazem Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules recalled	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules recalled	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide