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Par Pharmaceutical Recalls
17 recalls on record · January 14, 2015 to September 2, 2020 · 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.
September 2, 2020DrugsFDA
Par Pharmaceutical Inc. recalls BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Hazard: Failed Impurity /Degradation Specifications
April 8, 2020DrugsFDA
Par Pharmaceutical Inc. recalls Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.
Hazard: Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
March 25, 2020DrugsFDA
Par Pharmaceutical Inc. recalls PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977,
Hazard: Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
February 19, 2020DrugsFDA
Par Pharmaceutical Inc. recalls Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Alm
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
May 15, 2019DrugsFDA
Par Pharmaceutical, Inc. recalls Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chest
Hazard: Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
September 19, 2018DrugsFDA
Par Pharmaceutical, Inc. recalls Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: P
Hazard: Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
December 7, 2016DrugsFDA
Par Pharmaceutical, Inc. recalls Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in In
Hazard: Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
November 9, 2016DrugsFDA
Par Pharmaceutical, Inc. recalls Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate table
Hazard: Subpotent Drug; Ethinyl Estradiol
November 9, 2016DrugsFDA
Par Pharmaceutical, Inc. recalls Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablet
Hazard: Subpotent Drug; Ethinyl Estradiol
November 9, 2016DrugsFDA
Par Pharmaceutical, Inc. recalls Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, U
Hazard: Subpotent Drug; Ethinyl Estradiol
November 9, 2016DrugsFDA
Par Pharmaceutical, Inc. recalls Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 06
Hazard: Subpotent Drug; Ethinyl Estradiol
November 9, 2016DrugsFDA
Par Pharmaceutical, Inc. recalls Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (ND
Hazard: Subpotent Drug; Ethinyl Estradiol
June 22, 2016DrugsFDA
Par Pharmaceutical recalls Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmac
Hazard: Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
November 25, 2015DrugsFDA
Par Pharmaceutical Inc. recalls Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bot
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurities.
November 25, 2015DrugsFDA
Par Pharmaceutical Inc. recalls Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurities.
March 4, 2015DrugsFDA
Par Pharmaceutical Inc. recalls Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharma
Hazard: Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
January 14, 2015DrugsFDA
Par Pharmaceutical Inc. recalls HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, In
Hazard: Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.