DermOtic Oil (Hill Dermaceuticals) - Glass Contamination (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20
Brand
Hill Dermaceuticals, Inc.
Lot Codes / Batch Numbers
Lot #: 19K036D, 19L039E Exp. 05/21, 20A001E, 20A003D, 20A003E, Exp. 07/21, 20C013G Exp. 09/21, 20E025F, 20E025G, 20E025H Exp. 12/21, 20H041D, 20H041F Exp. 02/22, 20J043E Exp. 03/22, 20K050F Exp. 04/22, 20L055E Exp. 06/22, 21C015E, 21C018E Exp. 09/22
Products Sold
Lot #: 19K036D, 19L039E Exp. 05/21; 20A001E, 20A003D, 20A003E, Exp. 07/21; 20C013G Exp. 09/21; 20E025F, 20E025G, 20E025H Exp. 12/21; 20H041D, 20H041F Exp. 02/22; 20J043E Exp. 03/22; 20K050F Exp. 04/22; 20L055E Exp. 06/22; 21C015E, 21C018E Exp. 09/22
Hill Dermaceuticals, Inc. is recalling DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: due to Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026