Stop using now Drug recall · FDA · Published February 25, 2015

Heritage Recalls Colistimethate Injection Due to Sterility Risks

Heritage Pharmaceuticals recalls specific lots of Colistimethate for Injection USP due to lack of sterility assurance. Check lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0415-2015Drug Heritage Pharmaceuticals ›

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

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Contact the company

Recalling firmHeritage Pharmaceuticals, Inc.12 Christopher Way, Suite 300 · Eatontown, NJ 07724-3330

✎ GovInfoNow plain-language explainer

Heritage Pharmaceuticals is recalling two injectable products, specifically Colistimethate for Injection USP (150 mg per vial), because of concerns with quality control processes that may affect sterility. The recall covers multiple lots distributed nationwide. Because the product is intended for injection, ensuring it is sterile is critical to prevent infection. Read more at govinfonow.com/recall/44917-heritage-pharmaceuticals-inc-recalls-colistimethate-for-injection-usp-150-mg.

Source Summary by GovInfoNow · govinfonow.com/recall/44917-heritage-pharmaceuticals-inc-recalls-colistimethate-for-injection-usp-150-mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-0415-2015

Cite this page

“Heritage Recalls Colistimethate Injection Due to Sterility Risks.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44917-heritage-pharmaceuticals-inc-recalls-colistimethate-for-injection-usp-150-mg. Based on FDA recall #D-0415-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0415-2015%22&limit=1).

Heritage Pharmaceuticals Inc. recalled Colistimethate for Injection USP due to sterility concerns, the FDA said on Feb. 25, 2015. The agency announced the Class II recall of the drug manufactured by Emcure Pharmaceuticals Ltd.

How to tell if you have it

Brand: Heritage Pharmaceuticals
Product: Colistimethate for Injection USP, 150 mg per vial
NDC: 23155-193-31
Lot codes: VCOA002 (Exp. 09/14), VCOA003 (Exp. 10/14), VCOA004 (Exp. 10/14), VCOA005 (Exp. 01/15), VCOA006 (Exp. 03/15), VCOA007 (Exp. 09/15), VCOA008 (Exp. 12/15), VCOA009 (Exp. 02/16), VCOA010 (Exp. 10/16), VCOA011 (Exp. 10/16)
Distribution: Nationwide

The hazard

The recall addresses a lack of assurance of sterility due to concerns with quality control processes, according to the FDA.

Context

GovInfoNow's records show Heritage Pharmaceuticals Inc. has 11 other recalls on record since March 25, 2015. Other recent recalls include a July 30, 2026 recall of Clindamycin Oral Solution due to foreign particles and an Oct. 6, 2025 recall of Desipramine Tablets for N-Nitroso impurity risk. Similar recent recalls of injectable products include a Sept. 24, 2026 Tirzepatide Injection recall by Apothecary Pharma, a June 24, 2026 Bortezomib Injection recall by Reliance, and a Sept. 10, 2026 Quad-Mix Injectable recall by Carolina Infusion.

How to tell if you have this one

Look for vials labeled 'Colistimethate for Injection USP, 150 mg per vial' manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage Pharmaceuticals Inc. Affected lots include VCOA002 (Exp. 09/14), VCOA003 (Exp. 10/14), VCOA004 (Exp. 10/14), VCOA005 (Exp. 01/15), VCOA006 (Exp. 03/15), VCOA007 (Exp. 09/15), VCOA008 (Exp. 12/15), VCOA009 (Exp. 02/16), VCOA010 (Exp. 10/16), and VCOA011 (Exp. 10/16). The NDC is 23155-193-31.

Brand
Heritage Pharmaceuticals
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide

Recall number	Product, codes & lots	Quantity	NDC
D-0415-2015	Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31; Lot # VCOA002; Exp. 09/14, VCOA003; Exp. 10/14, VCOA004; Exp. 10/14 VCOA005; Exp. 01/15, VCOA006; Exp 03/15, VCOA007; Exp 09/15, VCOA008; Exp. 12/15, VCOA009; Exp. 02/16, VCOA010; Exp. 10/16 VCOA011; Exp. 10/16	—	23155-193-41, 23155-193-31
D-0416-2015	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; Lot # VRIA002; Exp. 08/16, VRIA003; Exp. 09/16, VRIA004; Exp. 09/16	24,344 vials	—

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Verify if your vials match the recalled lot numbers listed in the record, such as VCOA002 through VCOA011.
Contact Healthcare Provider
If you have one of these lots, contact your healthcare provider or pharmacist immediately for guidance on replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

Feb 25, 2015Firm started the recall
Mar 17, 2015FDA classified it Class II
Mar 25, 2015Published in FDA’s Enforcement Report
Feb 26, 2016FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Who manufactured this product?

The product was manufactured by Emcure Pharmaceuticals Ltd. in Hinjwadi, Pune, India, for Heritage Pharmaceuticals Inc.

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Link to this recall

<a href="https://govinfonow.com/recall/44917-heritage-pharmaceuticals-inc-recalls-colistimethate-for-injection-usp-150-mg">Heritage Recalls Colistimethate Injection Due to Sterility Risks (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0415-2015 (February 25, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0415-2015 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.