Lupin Pharmaceuticals Inc. recall records

7 reported ongoing

54 records in this archive. Latest source date Aug 3, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA drug enforcement

Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Auranga...

Subpotent Drug and Failed Impurities/Degradation Specifications

Class IIReported terminated

Distribution: Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.

Official source for Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, I...
FDA drug enforcement

Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Auranga...

Subpotent Drug and Failed Impurities/Degradation Specifications

Class IIReported terminated

Distribution: Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.

Official source for Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, I...
FDA drug enforcement

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, Mary...

CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

Class IIReported terminated

Distribution: Product was distributed nationwide.

Official source for Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02)...
FDA drug enforcement

Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited,...

Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

Class IIIReported terminated

Distribution: Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.

Official source for Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Phar...
FDA drug enforcement

Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets e...

Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test

Class IReported terminated

Distribution: USA nationwide.

Official source for Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg a...
FDA drug enforcement

Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 Ind...

Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.

Class IIReported terminated

Distribution: Distributed Nationwide in the USA

Official source for Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals ...
FDA drug enforcement

Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Class IIReported terminated

Distribution: Product was distributed by major distribution chains nationwide.

Official source for Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Ba...
FDA drug enforcement

Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Class IIReported terminated

Distribution: Product was distributed by major distribution chains nationwide.

Official source for Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Ba...
FDA drug enforcement

Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 ...

Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.

Class IIReported terminated

Distribution: Product was distributed to major distributors/wholesalers nationwide.

Official source for Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceutica...
FDA drug enforcement

Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, N...

Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.

Class IIReported terminated

Distribution: Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.

Official source for Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Phar...

Reasons in these listed records

  • Labeling: Incorrect or Missing Package Insert
  • Subpotent Drug and Failed Impurities/Degradation Specifications
  • Failed Impurities/Degradation Specifications
  • CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

These examples come from this result page and are not a ranking of every recall reason.

Checking Lupin Pharmaceuticals Inc.

Is there a recall on lupin pharmaceuticals inc. right now?

This archive contains 54 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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