Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
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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.
FDA RecallTerminatedTerminated: July 1, 2020Historical recordClass II
Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
by Lupin Pharmaceuticals Inc.
Reason
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
FDA RecallTerminatedTerminated: June 26, 2020Historical recordClass III
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01
by Lupin Pharmaceuticals Inc.
Reason
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
FDA RecallTerminatedTerminated: June 22, 2020Historical recordClass III
Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
by Lupin Pharmaceuticals Inc.
Reason
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
FDA RecallTerminatedTerminated: April 8, 2020Historical recordClass II
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01
by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
FDA RecallTerminatedTerminated: August 18, 2020Historical recordClass I
Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
by Lupin Pharmaceuticals Inc.
Reason
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
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.
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