Recall Register

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Par Pharmaceutical Inc.

FDA recalling firm · 11 enforcement events · 16 product records · 2014–2020 · NY

Par Pharmaceutical Inc. has 11 FDA enforcement events on this register (16 product records) between 2014 and 2020: 11 drug; the busiest year was 2020 with 4.

9% of its events are Class I; the most common class is Class II (5). 0 events are listed as ongoing; the recalling firm's address is in NY.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
10 Aug 2020BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01DrugClass II1Terminated
30 Mar 2020Glycopyrrolate 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# 49884-0065-01DrugClass II1Terminated
4 Mar 2020PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31DrugClass III1Terminated
10 Feb 2020Frovatriptan 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.DrugClass III1Terminated
30 Apr 2019Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044DrugClass I1Terminated
6 Sep 2018Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11DrugClass III1Terminated
5 Oct 2016Travoprost 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 10977DrugClass II1Terminated
27 Sep 2016Gildess 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 PHARMACEUTICALS, USA, Huntsville, AL 35811DrugClass III5Completed
26 Oct 2015Meclizine 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.DrugClass III2Terminated
12 Feb 2015Mafenide 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 49884-902-78 (cartons of five 50 g packets)DrugClass II1Terminated
24 Nov 2014HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977DrugClass II1Terminated

By type and class

Drug11
Class II5
Class III5
Class I1

Class I: 9% of this firm's events; 18% of all events on the register.

Events by year

14
16
18
20
22
24
26
Enforcement events for Par Pharmaceutical Inc. by year initiated.

Questions and answers

How many FDA recalls has Par Pharmaceutical Inc. had?

11 enforcement events (16 product records) on this register, 2014–2020: 11 drug.

Are any Par Pharmaceutical Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Par Pharmaceutical Inc. recalls?

5 Class II, 5 Class III, 1 Class I. 9% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.