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Actavis Inc

FDA Regulatory Profile

Actavis Inc has 20 FDA recalls, 12 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Actavis Inc" and its spelling variants "Actavis", "Actavis Incorporated". They do not include records filed under Teva or other names in its corporate family.

Latest recall
D-0514-2017 · Class III · Feb 7, 2017
Latest inspection
Nov 22, 2024 · NAI

Part of the Teva corporate family.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls20Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections12Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Actavis Inc's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Actavis Inc: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 1 inspections120242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202410000
202300000
202200000
202100000
202000000
201910000
201810000
201700030

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

20 recall records from Jul 11, 2012 to Feb 7, 2017.

NumberClassProductDate
D-0514-2017Class IIILevofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by…Feb 7, 2017
D-0476-2017Class IIGlipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon…Jan 30, 2017
D-0439-2017Class IIIAlbuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for…Jan 12, 2017
D-1471-2016Class IIIAcetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured…Aug 2, 2016
D-1472-2016Class IIIHydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60…Aug 2, 2016
D-1448-2016Class IIDextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured…Jul 11, 2016
D-1457-2016Class IIGlipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon…Jun 30, 2016
D-1148-2015Class IIILutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet…Jun 4, 2015
D-0396-2015Class IIVancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for…Feb 12, 2015
D-0406-2015Class IIVancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for…Feb 12, 2015
D-0233-2015Class IIVancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson…Aug 25, 2014
D-0232-2015Class IIVancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson…Aug 25, 2014
D-1386-2014Class IIVancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx…May 16, 2014
D-1088-2014Class IIIGelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician…Feb 7, 2014
D-1085-2014Class IITrelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus…Dec 9, 2013
D-1043-2014Class IIIBuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC…Nov 15, 2013
D-855-2013Class IIIBuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only…Jul 31, 2013
D-599-2013Class IIIFentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count…Jun 3, 2013
D-1060-2014Class IIDiclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by…Mar 22, 2013
D-1693-2012Class IIFentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL…Jul 11, 2012

Recent FDA inspections

12 inspections from Sep 10, 2009 to Nov 22, 2024.

DateSiteProductClassificationFEI
Nov 22, 2024Edison, NJDrugsNo Action Indicated (NAI)3009017204
Aug 8, 2019Edison, NJDrugsNo Action Indicated (NAI)3009017204
May 7, 2018Edison, NJDrugsVoluntary Action Indicated (VAI)3009017204
Jul 7, 2016Edison, NJDrugsVoluntary Action Indicated (VAI)3009017204
Oct 29, 2013Edison, NJDrugsNo Action Indicated (NAI)3009017204
Apr 30, 2013Mt Prospect, ILDrugsNo Action Indicated (NAI)1419832
Mar 15, 2013Morristown, NJDrugsNo Action Indicated (NAI)3009211379
Oct 26, 2012Bucuresti, RomaniaDrugsVoluntary Action Indicated (VAI)3009532631
Jan 27, 2012Edison, NJDrugsNo Action Indicated (NAI)3009017204
Dec 1, 2011Mt Prospect, ILDrugsNo Action Indicated (NAI)1419832
May 25, 2010Mt Prospect, ILDrugsNo Action Indicated (NAI)1419832
Sep 10, 2009Mt Prospect, ILDrugsNo Action Indicated (NAI)1419832
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

4 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3009017204Edison, NJ6Nov 22, 2024
FEI 1419832Mt Prospect, IL4Apr 30, 2013
FEI 3009211379Morristown, NJ1Mar 15, 2013
FEI 3009532631Bucuresti, Romania1Oct 26, 2012

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.