Skip to main content

Lupin Pharmaceuticals Inc.

7 ongoing recalls and 116 historical records

Based on the official records currently available to Public Health Trace, 7 recalls naming Lupin Pharmaceuticals Inc. are currently shown as ongoing. The other 116 records below are historical.

Public Health Trace has 123 recalls naming Lupin Pharmaceuticals Inc. as the recalling firm, republished from official FDA and USDA sources.

Recall records - 123 total

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20181
201925
202019
202111
202214
20235
202414
20257
20264
Download CSV

FDA Recall TerminatedTerminated: January 5, 2026Historical recordClass II

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Published
November 27, 2024
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: January 5, 2026Historical recordClass II

Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Published
November 27, 2024
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: April 29, 2025Historical recordClass II

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

by Lupin Pharmaceuticals Inc.

Reason
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Published
September 4, 2024
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: April 29, 2025Historical recordClass II

Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03

by Lupin Pharmaceuticals Inc.

Reason
Failed Content Uniformity Specifications
Published
June 26, 2024
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: April 29, 2025Historical recordClass II

Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04

by Lupin Pharmaceuticals Inc.

Reason
Defective container: lack of seal integrity.
Published
June 5, 2024
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: April 29, 2025Historical recordClass II

Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04

by Lupin Pharmaceuticals Inc.

Reason
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Published
May 22, 2024
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: April 29, 2025Historical recordClass II

Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04

by Lupin Pharmaceuticals Inc.

Reason
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Published
May 22, 2024
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: April 4, 2025Historical recordClass II

Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06

by Lupin Pharmaceuticals Inc.

Reason
Subpotent Drug
Published
April 17, 2024
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: December 27, 2024Historical recordClass II

Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.

by Lupin Pharmaceuticals Inc.

Reason
Labeling: Incorrect or Missing Package Insert
Published
February 28, 2024
Distribution
Multiple states

View recall →

FDA Recall TerminatedTerminated: August 27, 2024Historical recordClass II

Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06

by Lupin Pharmaceuticals Inc.

Reason
Subpotent Drug and Failed Impurities/Degradation Specifications
Published
February 7, 2024
Distribution
Product was distributed to 32 Wholesale/…

View recall →

FDA Recall TerminatedTerminated: August 27, 2024Historical recordClass II

Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06

by Lupin Pharmaceuticals Inc.

Reason
Subpotent Drug and Failed Impurities/Degradation Specifications
Published
February 7, 2024
Distribution
Product was distributed to 32 Wholesale/…

View recall →

FDA Recall TerminatedTerminated: December 27, 2024Historical recordClass II

Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications
Published
February 7, 2024
Distribution
Nationwide

View recall →

Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name Lupin Pharmaceuticals Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.

Reconnecting to the server…

We lost the connection to the server.

Your session has expired.