CLASS II Drug recall · Reported 25 Mar 2015 · FDA Enforcement Report

Rifampin for Injection,USP, 600 mg per vial recalled

Heritage Pharmaceuticals is recalling Rifampin for Injection,USP, 600 mg per vial, distributed nationwide in the US. The recall was initiated on 25 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # VRIA002; Exp. 08/16, VRIA003; Exp. 09/16, VRIA004; Exp. 09/16

Quantity recalled24,344 vials

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-0416-2015
FDA event ID: 70592
Recalling firm: Heritage Pharmaceuticals, Eatontown, NJ
Classification: Class II
Status: Terminated
Recall initiated: 25 Feb 2015
FDA classified: 17 Mar 2015
Reported: 25 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

25 Feb 2015	Recall initiated by company
17 Mar 2015	Classified by FDA	+20 days
25 Mar 2015	Published in enforcement report	+8 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: Firm is recalling two injectable products due to concerns with quality control processes.

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

RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.

Which lots are affected?

Lot # VRIA002; Exp. 08/16, VRIA003; Exp. 09/16, VRIA004; Exp. 09/16

Where was it sold?

Nationwide

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

1 other product · FDA event 70592

This product is part of a recall event; the main page for the event is Colistimethate for Injection USP, 150 mg per vial recalled.

Reported	Class	Recall	Company	Reason	Where
25 Mar 2015	CLASS II	Colistimethate for Injection USP, 150 mg per vial recalledColistimethate Sodium	Heritage Pharmaceuticals	Sterility	Nationwide

More recalls from Heritage Pharmaceuticals

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19 Aug 2026Drug	CLASS II	Clindamycin Palmitate Hydrochloride For Oral Solution, USP, 75 mg recalledClindamycin Palmitate Hydrochloride	Heritage Pharmaceuticals	Particulate Matter	Nationwide
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5 Nov 2025Drug	CLASS II	Desipramine Hydrochloride Tablets, USP, 100 mg bottle recalledDesipramine Hydrochloride	Heritage Pharmaceuticals	Nitrosamine Impurity	Nationwide
5 Nov 2025Drug	CLASS II	Desipramine Hydrochloride Tablets, USP, 50 mg bottle recalledDesipramine Hydrochloride	Heritage Pharmaceuticals	Nitrosamine Impurity	Nationwide
5 Nov 2025Drug	CLASS II	Desipramine Hydrochloride Tablets, USP, 10 mg bottle recalledDesipramine Hydrochloride	Heritage Pharmaceuticals	Nitrosamine Impurity	Nationwide

Other Rifampin recalls

All 21

Reported	Class	Recall	Company	Reason	Where
17 Apr 2024Drug	CLASS II	Rifampin Capsules USP, 300mg recalled by Lupin Pharmaceuticals	Lupin Pharmaceuticals	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS II	Rifampin Capsules USP 300mg recalled by Lupin PharmaceuticalsRifampin	Lupin Pharmaceuticals	Potency & Assay	MD
7 Feb 2024Drug	CLASS II	Rifampin Capsules USP, 150 mg doses recalled	Amerisource Health Services	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS II	Rifampin Capsules USP 150mg recalled by Lupin PharmaceuticalsRifampin	Lupin Pharmaceuticals	Potency & Assay	MD
7 Jun 2023Drug	CLASS II	Rifampin Capsules USP, 150 mg recalled by Akorn	Akorn	Potency & Assay	Nationwide