Lupin Pharmaceuticals Ceftriaxone for Injection Recall

Why it was recalled

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Product description

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 numbers, UPCs & expiration codes

Lot #: C500037, Exp 01/18

Where it was sold

Nationwide and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0954-2016
Classification: Class III
Status: Terminated
Recall initiated: Mar 11, 2016
FDA report date: Jun 8, 2016
Quantity: 570 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Lupin Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0954-2016, exactly as published.

Show all FDA fields

City: Baltimore
State: MD
Status: Terminated
Country: United States
Event ID: 73830
Address: 111 S Calvert St Fl 21ST
Code information: Lot #: C500037, Exp 01/18
Postal code: 21202-6174
Report date: Jun 8, 2016
Product type: Drugs
Recall number: D-0954-2016
Classification: Class III
Recalling firm: Lupin Pharmaceuticals Inc.
Product quantity: 570 vials
Termination date: Aug 14, 2017
Reason for recall: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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.
Distribution pattern: Nationwide and Puerto Rico
Recall initiation date: Mar 11, 2016
Initial firm notification: E-Mail
Center classification date: Jun 2, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0954-2016, published Jun 8, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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