Par Pharmaceutical recalls

Par Pharmaceutical has 17 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 2 Sep 2020. The most frequent reason is potency & assay.

Total recalls17since 2015
Last 12 months0reported
Class I16% of total
Ongoing0latest 2 Sep 2020

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 1 6%Class II 5 29%Class III 11 65%

Why par pharmaceutical is recalled

By year

All par pharmaceutical recalls, newest first

17 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIBusPIRone Hydrochloride Tablets, USP 7.5 mg recalledPar PharmaceuticalPotency & AssayNationwide
DrugCLASS IIGlycopyrrolate Tablets, USP 1 mg recalled by Par PharmaceuticalPar PharmaceuticalPotency & AssayNY
DrugCLASS IIIPrediniSONE Tablets, USP 5 mg recalled by Par PharmaceuticalPrednisonePar PharmaceuticalOtherNationwide
DrugCLASS IIIFrovatriptan Succinate Tablets, 2.5mg recalled by Par PharmaceuticalPar PharmaceuticalLabeling ErrorsNationwide
DrugCLASS IMycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalledMycophenolate MofetilPar PharmaceuticalParticulate MatterNationwide
DrugCLASS IIIPramipexole dihydrochloride extended release tablets, 0.75 mg recalledPar PharmaceuticalPotency & AssayNationwide
DrugCLASS IITravoprost Ophthalmic Solution USP, 0.004%, a) and b) recalledPar PharmaceuticalSterilityNationwide
DrugCLASS IIIGildess 1/20 (norethindrone acetate, 1 mg recalled by Par PharmaceuticalPar PharmaceuticalPotency & AssayNationwide
DrugCLASS IIIGildess FE 1.5/30 (norethindrone acetate, 1.5 mg recalledPar PharmaceuticalPotency & AssayNationwide
DrugCLASS IIIGildess 1.5/30 (norethindrone acetate, 1.5 mg recalledPar PharmaceuticalPotency & AssayNationwide
DrugCLASS IIIGildess 24 FE 1.5/30 (norethindrone acetate, 1 mg recalledPar PharmaceuticalPotency & AssayNationwide
DrugCLASS IIIGildess FE 1/20 (norethindrone acetate, 1 mg recalledPar PharmaceuticalPotency & AssayNationwide
DrugCLASS IIIPramipexole Dihydrochloride Extended Release Tablets, 0.375 mg recalledPar PharmaceuticalPotency & AssayNationwide
DrugCLASS IIIMeclizine Hydrochloride Tablets recalled by Par PharmaceuticalPar PharmaceuticalPotency & AssayNationwide
DrugCLASS IIIMeclizine Hydrochloride Tablets recalled by Par PharmaceuticalPar PharmaceuticalPotency & AssayNationwide
DrugCLASS IIMafenide Acetate, USP, For 5% Topical Solution, Sterile recalledPar PharmaceuticalOtherNationwide
DrugCLASS IIHydrALAZINE Hydrochloride Tablets, USP 25 mg recalledPar PharmaceuticalParticulate MatterNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.