Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
WHO, and other public sources. It is an independent information service, not a medical provider, and
not a substitute for professional medical advice or your local public health department's own guidance.
Policy version 2026-07-21, effective July 21, 2026.
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Based on the official records currently available to Public Health Trace, no recalls naming Actavis Inc are currently shown as ongoing. The 17 records below are historical recall records.
Public Health Trace has 17 recalls naming Actavis Inc as the recalling firm, republished from official FDA and USDA sources.
Recall history - 17 terminated records
Recalls by year
A bar chart of the number of recalls naming this company by year.
FDA RecallTerminatedTerminated: February 8, 2017Historical recordClass III
Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61
by Actavis Inc
Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
FDA RecallTerminatedTerminated: February 8, 2017Historical recordClass III
Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
by Actavis Inc
Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
FDA RecallTerminatedTerminated: April 12, 2016Historical recordClass III
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc., Mississauga, Ontario L9N7K9 Canada, NDC 52544-0949-28
by Actavis Inc
Reason
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Some FDA recall records on this page come from FDA's Enforcement Report database.
Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
This page lists recalls that name Actavis Inc as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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