Use caution Drug recall · FDA · Published December 20, 2018

Lupin Ceftriaxone Injection Recall: Grey Flecks Risk

Lupin Pharmaceuticals recalls 250mg Ceftriaxone injection vials due to grey flecks from shredded rubber. Product complaints indicate particulate matter in reconstituted vials.

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

🇺🇸 FDA recall #D-0355-2019Drug Lupin Pharmaceuticals ›

Use caution until it’s fixed

Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

Take action

Contact the company

Recalling firmLupin Pharmaceuticals Inc.111 S Calvert St Fl 21ST · Baltimore, MD 21202-6174

✎ GovInfoNow plain-language explainer

Lupin Pharmaceuticals is recalling 250 mg Ceftriaxone for Injection USP vials after reports of grey flecks (shredded rubber) in reconstituted vials. This could cause serious issues if injected. Read more at govinfonow.com/recall/39296-lupin-ceftriaxone-injection-recall-grey-flecks-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39296-lupin-ceftriaxone-injection-recall-grey-flecks-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0355-2019

Cite this page

“Lupin Ceftriaxone Injection Recall: Grey Flecks Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39296-lupin-ceftriaxone-injection-recall-grey-flecks-risk. Based on FDA recall #D-0355-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0355-2019%22&limit=1).

The FDA announced on 2018-12-20 that Lupin Pharmaceuticals Inc. is recalling Ceftriaxone for Injection USP, 250 mg, due to the presence of particulate matter. The agency classified the recall as Class I.

How to tell if you have it

Brand: Lupin Pharmaceuticals
Product: Ceftriaxone for Injection USP, 250 mg
NDC 68180-611-01 (one Single Use Vial)
NDC 68180-611-10 (10 Single Use Vials per box)
Lot codes: C600142, C600136, C600182, C700147, C700207
Expiration dates: 08/19, 09/19, 05/20

The hazard

The recall addresses product complaints of grey flecks identified as shredded rubber particulate matter from the stopper observed in reconstituted vials. The FDA classified this hazard as Class I.

Context

GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since 2013-01-31. Other recent recalls of similar products include Lupin Clobetasol Cream Recall (2026-08-03), Lupin Glucagon Emergency Kit Recall (2026-06-23), and Lupin prednisolone acetate ophthalmic suspension recall (2026-06-04). Other recent recalls of similar products include American Regent Epinephrine Injection Recall (2026-08-11), Sun Pharmaceutical DOXOrubin Liposome Injection Recall (2026-05-12), and Sunny Pharmtech Cyclophosphamide Injection Recall (2026-07-17).

How to tell if you have this one

Check for vials labeled 'Ceftriaxone for Injection USP, 250 mg' with NDC 68180-611-01 (single vial) or NDC 68180-611-10 (10 vials per box).

Brand
Lupin Pharmaceuticals
Category
Drug

FDA recall event · 4 products

All 4 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 I
Status
Terminated
Distribution
Nationwide in the USA and Puerto Rico.

Recall number	Product, codes & lots	Quantity
D-0355-2019	Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.; Lot #: a) C600142, Exp 08/19; b) C600136, Exp 08/19; C600182, Exp 09/19, C700147, Exp 05/20; C700207, Exp 09/20 Additional lots added 12/19/2018 - C600142, C700147 and C700207	a) 12,000 vials; b) 11,763 boxes
D-0356-2019	Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.; Lot #: a) C600173, Exp 08/19; C600218, Exp 09/19; b) C600126, C600127, C600137, C600143, Exp 08/19; C600219, Exp 09/19; C700146, Exp 05/20; C700208, C700209, Exp 09/20.	a) 8,000 vials; b) 32,045 boxes
D-0357-2019	Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.; Lot #: a) C600110, Exp 05/19; C600130, Exp 08/19; C700113, Exp 03/20; C700143, Exp 05/20; b) C600106, C600108, Exp 05/19; C600128, C600138, Exp 08/19; C600174, C600179, C600180, C600181, Exp 09/19; C700108, C700109, C700110, C700111, C700112, Exp 03/20; C700129, C700130, C700131, C700132, C700138, C700142, C700145, Exp 05/20	a) 35,000 vials; b) 112,641 boxes
D-0358-2019	Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.; Lot #: C600109, Exp 05/19; C600129, C600135, Exp 08/19	3,792 boxes

Based on the official FDA remedy

What to do — step by step

Check Vial Labels
Look for NDC codes 68180-611-01 or 68180-611-10 on the vial packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Dec 20, 2018Firm started the recall
Jan 14, 2019FDA classified it Class I
Jan 16, 2019Published in FDA’s Enforcement Report
Aug 18, 2020FDA 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

Are there any specific lot numbers I should check?

Yes, the recall includes specific lot numbers: C600142, C600136, C600182, C700147, C700207 with expiration dates through 2020.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/39296-lupin-ceftriaxone-injection-recall-grey-flecks-risk">Lupin Ceftriaxone Injection Recall: Grey Flecks Risk (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-0355-2019 (December 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0355-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.