The Recall Desk

Manufacturer

Par Pharmaceutical, Inc.

16 recalls in our database name Par Pharmaceutical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
4
Most recent
2020-09-02

Of the 16 recalls from Par Pharmaceutical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (25%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

  • SevereFDA (Drugs)·D-1071-2020·2020-04-08

    Par Pharmaceutical Recalls Glycopyrrolate Tablets Due to Unknown Impurity

    Par Pharmaceutical is recalling 29,352 bottles of Glycopyrrolate Tablets, USP 1 mg, because an unknown impurity was detected.

    Product
    Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0843-2020·2020-02-19

    Par Pharmaceutical Recalls Frovatriptan Tablets Due to Incorrect Expiration Date

    Par Pharmaceutical is recalling 9,936 cartons of Frovatriptan Succinate Tablets, 2.5mg, because they are labeled with an incorrect expiration date.

    Product
    Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1185-2018·2018-09-19

    Par Pharmaceutical Recalls Pramipexole Dihydrochloride Extended Release Tablets

    Par Pharmaceutical is recalling Pramipexole dihydrochloride extended release tablets because they contain a known impurity at levels exceeding specifications.

    Product
    Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0154-2017·2016-12-07

    Par Pharmaceutical Recalls Travoprost Ophthalmic Solution Due to Sterility Concerns

    Par Pharmaceutical is recalling specific lots of Travoprost Ophthalmic Solution because the dropper tips may be damaged, compromising sterility.

    Product
    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 India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0123-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 24 FE 1.5/30 Oral Contraceptives

    Par Pharmaceutical is recalling Gildess 24 FE 1.5/30 oral contraceptives because the ethinyl estradiol component is subpotent. The recall covers 44,127 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0120-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 1/20 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess 1/20 tablets because they contain subpotent levels of ethinyl estradiol. The recall covers 393,981 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARM
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0119-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 1.5/30 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess 1.5/30 tablets because they contain subpotent levels of ethinyl estradiol. The recall covers specific lots distributed nationwide and in Puerto Rico.

    Product
    Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST P
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0121-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess FE 1/20 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess FE 1/20 tablets because the ethinyl estradiol component is subpotent. The recall covers 822,009 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHAR
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0122-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess FE 1.5/30 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess FE 1.5/30 tablets because they may contain subpotent levels of ethinyl estradiol.

    Product
    Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0234-2016·2015-11-25

    Par Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures

    Par Pharmaceutical is recalling Meclizine Hydrochloride Tablets because they failed impurity specifications. The recall covers 100 and 1000-count bottles distributed nationwide.

    Product
    Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0233-2016·2015-11-25

    Par Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurities

    Par Pharmaceutical is recalling specific lots of Meclizine Hydrochloride 12.5 mg tablets because they failed impurity specifications.

    Product
    Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0393-2015·2015-03-04

    Par Pharmaceutical Recalls Mafenide Acetate Topical Solution Due to Foreign Substances

    Par Pharmaceutical Inc. is recalling Mafenide Acetate 5% Topical Solution packets due to the presence of oxidized steel, organic material, and shredded polypropylene.

    Product
    Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label --- Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Made in India -- NDC 49884-902-52 (packets of 50 g) and NDC 4988
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0332-2015·2015-01-14

    Par Pharmaceutical Recalls HydrALAZINE Tablets Due to Aluminum Particles

    Par Pharmaceutical is recalling one lot of HydrALAZINE Hydrochloride tablets because small aluminum particles were found in the product.

    Product
    HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Par Pharmaceutical

Founded
1978

Official website

Source: Wikidata (Q7133598), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.