Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Ear Drops
Hill Dermaceuticals is recalling 13,591 bottles of Fluocinolone Acetonide 0.01% Oil Ear Drops because routine testing found the active ingredient to be subpotent.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a subpotent active ingredient, which is a quality issue rather than a direct safety hazard like contamination or mislabeling of a common allergen.
Plain-English summary
Hill Dermaceuticals, Inc. is recalling 13,591 bottles of SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only. The product is manufactured by Hill Dermaceuticals, Inc. for Seton Pharmaceuticals under NDC 13925-508-20.
The recall was initiated because the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. The affected lots are identified by codes 13F017B and 13F020B, both with an expiration date of 12/14.
The product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase.
The recalled product
- Product
- SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20
- Manufacturer
- Hill Dermaceuticals, Inc.
- Category
- Drug — Ophthalmic/Ear Drops
- Hazard
- Affected units
- 13,591
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 13F017B exp. 12/14
- 13F020B exp 12/14
Distribution
Part of a larger recall action
This product is one of 9 recalled by Hill Dermaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Hill Dermaceuticals, Inc.
See all →- HighDermOtic fluocinolone acetonide ear drops recalled for broken glass risk
FDA (Drugs) · 2021-06-30
- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
FDA (Drugs) · 2014-04-02
- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
FDA (Drugs) · 2014-04-02
- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
FDA (Drugs) · 2014-04-02
- ModerateHill Dermaceuticals Recalls Subpotent Dermotic Ear Drops
FDA (Drugs) · 2014-04-02
Same hazard · subpotent drug
See all →- ModerateAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02