Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported June 30, 2021
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
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Hill Dermaceuticals, Inc. recalled DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manuf… - a moderate-severity action.
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manuf… was recalled by Hill Dermaceuticals, Inc. in June 30, 2021. Reason: Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.. Check the official notice for the remedy. Verify recall #D-0637-2021 with the FDA Drug before acting.
The recall
Hill Dermaceuticals, Inc. issued this moderate-severity FDA Drug recall-Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper..
- Moderate
- severity level
- Class II
- classification
- June 30, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0637-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0637-2021) was formally reported on June 30, 2021, with the manufacturer initiating the action on May 21, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Hill Dermaceuticals, Inc. is listed as the recalling firm, operating out of Sanford, FL. Federal records list the affected scope as 34,561 bottles for sale; 773 bottles for samples.
The documented reason for this recall is: Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. Distribution data in the federal record shows the product reached: Nationwide within the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
34,561 bottles for sale; 773 bottles for samples
Related Recalls
6
5 from same agency
Product description
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
Reason for recall
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0637-2021 |
| Date reported | June 30, 2021 |
| Date initiated | May 21, 2021 |
| Recalling firm | Hill Dermaceuticals, Inc. |
| Firm location | Sanford, FL |
| Affected scope | 34,561 bottles for sale; 773 bottles for samples |
| Distribution | Nationwide within the United States |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0637-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hill Dermaceuticals, Inc.. Units affected: 34,561 bottles for sale; 773 bottles for samples.
Why was this product recalled? ▼
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 30, 2021. Severity: Moderate. Recall number: D-0637-2021.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the United States.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0637-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported June 30, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.