Lupin Pharmaceuticals Inc. Recalls Recalls by year
A bar chart of the number of recalls naming this company by year.
Recalls by year
Year Recalls 2018 2 2019 25 2020 19 2021 11 2022 14 2023 5 2024 14 2025 7 2026 3
Download CSV FDA Recall
Terminated
Historical record Class 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
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FDA Recall
Terminated
Historical record Class 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
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FDA Recall
Terminated
Historical record Class 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
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FDA Recall
Terminated
Historical record Class 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
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FDA Recall
Terminated
Historical record Class 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
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FDA Recall
Terminated
Historical record Class 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
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FDA Recall
Terminated
Historical record Class 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
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FDA Recall
Terminated
Historical record Class 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
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FDA Recall
Terminated
Historical record Class 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/…
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FDA Recall
Terminated
Historical record Class 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
Terminated
Historical record Class 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 →
FDA Recall
Terminated
Historical record Class II
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202. by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit. Published
January 17, 2024 Distribution
Nationwide
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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.
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