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Lupin Pharmaceuticals Recalls
122 recalls on record · April 24, 2013 to July 8, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 6, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryl
Hazard: 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.
January 23, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, In
Hazard: CGMP Deviation; manufacturing batch record could not be located
January 16, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only
Hazard: CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
January 16, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only
Hazard: CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
January 16, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured fo
Hazard: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
January 16, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per
Hazard: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
January 16, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials
Hazard: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
January 16, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials
Hazard: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
October 31, 2018DrugsFDA
Lupin Pharmaceuticals Inc. recalls Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimor
Hazard: Defective Container: Repetitive complaints received indicating pump not working.
August 22, 2018DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryl
Hazard: Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
August 8, 2018DrugsFDA
Lupin Pharmaceuticals Inc. recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimor
Hazard: Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
May 30, 2018DrugsFDA
Lupin Pharmaceuticals Inc. recalls My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per c
Hazard: Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
May 30, 2018DrugsFDA
Lupin Pharmaceuticals Inc. recalls My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per c
Hazard: Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
April 25, 2018DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs
Hazard: Superpotent Drug
December 6, 2017DrugsFDA
Lupin Pharmaceuticals Inc. recalls Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc.
Hazard: Failed Dissolution Specification
September 13, 2017DrugsFDA
Lupin Pharmaceuticals Inc. recalls Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Ba
Hazard: CGMP Deviations
July 19, 2017DrugsFDA
Lupin Pharmaceuticals Inc. recalls Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc
Hazard: Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
April 12, 2017DrugsFDA
Lupin Pharmaceuticals Inc. recalls Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
Hazard: Failed Impurities/Degradation Specifications; Impurity A
September 28, 2016DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD
Hazard: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
September 28, 2016DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-5
Hazard: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
July 6, 2016DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx
Hazard: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
June 8, 2016DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1
Hazard: CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
June 8, 2016DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644
Hazard: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
June 8, 2016DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633
Hazard: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
June 8, 2016DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b)
Hazard: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
June 8, 2016DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b)
Hazard: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
April 9, 2014DrugsFDA
Lupin Pharmaceuticals Inc. recalls Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Phar
Hazard: Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
April 9, 2014DrugsFDA
Lupin Pharmaceuticals Inc. recalls Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmac
Hazard: Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
January 22, 2014DrugsFDA
Lupin Pharmaceuticals Inc. recalls Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21
Hazard: Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
January 22, 2014DrugsFDA
Lupin Pharmaceuticals Inc. recalls Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 212
Hazard: Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval