Actavis Acetasol HC Otic Solution Recall: Impurities Risk
Actavis recalls hydrocortisone and acetic acid otic solution due to impurities detected at expiry. Rx-only 10mL bottles manufactured by Actavis Inc. No remedy specified in recall notice.
Recall notice
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).
Contact the company
What happened, in plain English
Actavis is recalling hydrocortisone and acetic acid otic solution (Acetasol HC) for potential impurities detected at the 12-month stability test. This recall affects prescription-only 10mL bottles manufactured by Actavis Inc. The impurities could pose a risk to users if the product is used after the expiration date. Read more at govinfonow.com/recall/42504-actavis-acetasol-hc-otic-solution-recall-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42504-actavis-acetasol-hc-otic-solution-recall-impurities-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-1471-2016
Cite this page
“Actavis Acetasol HC Otic Solution Recall: Impurities Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42504-actavis-acetasol-hc-otic-solution-recall-impurities-risk. Based on FDA recall #D-1471-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1471-2016%22&limit=1).
Why it’s dangerous
The recall indicates that the product showed impurities at the 12-month stability test. This suggests the product may not be safe for use after the expiration date due to potential degradation. However, the specific health risk from these impurities is not clearly described in the recall notice.
Who’s affected
Prescription-only users of Acetasol HC otic solution who have the 10mL bottles manufactured by Actavis Inc. Those with the product past its expiration date (April 2016) are most at risk.
How to tell if you have this one
Check for the 10mL bottle labeled 'Acetasol HC (hydrocortisone and acetic acid otic solution USP)' manufactured by Actavis Inc. The product was sold with NDC 0472-0882-82 and expired April 2016.
- Brand
Actavis- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1471-2016 | 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; L503092, Exp 04/2016 | 672 bottles |
| D-1472-2016 | 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; L503092, Exp 04/2016 | 2543 bottles |
What to do — step by step
Check Product Details
Identify if you have the 10mL bottle of Acetasol HC with NDC 0472-0882-82 manufactured by Actavis Inc.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1471-2016 (August 2, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1471-2016 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.