Lupin Recalls Ceftriaxone Vials Due to CGMP Deviations
Lupin Pharmaceuticals recalls specific lots of Ceftriaxone for Injection USP due to manufacturing deviations. Check your vial NDC and lot number.
Use caution until it’s fixed
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Contact the company
What happened, in plain English
Lupin Pharmaceuticals Inc. is recalling a small quantity of Ceftriaxone for Injection USP, 2 g single-use vials because the finished products were manufactured using active pharmaceutical ingredients whose intermediates failed specifications. This is a Current Good Manufacturing Practice (CGMP) deviation. The recall involves only 570 vials distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/43120-lupin-recalls-ceftriaxone-vials-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/43120-lupin-recalls-ceftriaxone-vials-due-to-cgmp-deviations · Updated October 11, 2026 · FDA enforcement record: FDA #D-0954-2016
Cite this page
“Lupin Recalls Ceftriaxone Vials Due to CGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43120-lupin-recalls-ceftriaxone-vials-due-to-cgmp-deviations. Based on FDA recall #D-0954-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0954-2016%22&limit=1).
Why it’s dangerous
The hazard stems from CGMP deviations where active pharmaceutical ingredients had intermediates that failed specifications during manufacturing. This means the quality control standards were not met, potentially affecting the product's purity or potency, though specific health outcomes are not detailed in the record.
Who’s affected
Healthcare providers and patients who received Ceftriaxone for Injection USP, 2 g single-use vials from the specific lots listed below. The record does not specify which patient populations are most at risk beyond those using this medication.
How to tell if you have this one
Look for Ceftriaxone for Injection USP, 2 g, Single Use Vial packaged in 10-count boxes. The NDC is 68180-644-01 (vial) and 68180-644-10 (box). Check for Lot # C500037 with an expiration date of 01/18.
- Brand
Lupin Pharmaceuticals- Category
Drug
All 5 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 III- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0951-2016 | Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count 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) C500031, Exp 12/17; b) C500026, Exp 12/17; C500036, C500043, Exp 01/18 | 15408 vials |
| D-0952-2016 | Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count 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) C500006, Exp 11/17; b) C500001, Exp 11/17 | 7908 vials |
| D-0953-2016 | Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count 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, NDC 68180-633-01.; Lot #: C400180, Exp 07/17; C500003, C500028, C500029, Exp 122/17; C500038, Exp 01/18; C500044, Exp 02/18 | 30586 vials |
| D-0954-2016 | Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.; Lot #: C500037, Exp 01/18 | 570 vials |
| D-0955-2016 | Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.; Lot #: B4000935, Exp 01/17; B4005178, Exp 06/17; B4008730, B4008729, B4008727, B4008724, Exp 10/17; B5001647, B5001648, B5001649, Exp 02/18 | 741.171 kg |
What to do — step by step
Check Inventory
Verify if you have vials matching NDC 68180-644-01, Lot # C500037, Exp 01/18.
Contact Supplier
The record does not state the specific remedy or return process; contact your supplier or Lupin Pharmaceuticals for instructions.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide 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 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0954-2016 (March 11, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0954-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.