Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported December 25, 2024
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Pro…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Keystone Industries recalled Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC … - a moderate-severity action.
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC … was recalled by Keystone Industries in December 25, 2024. Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing ves…. Check the official notice for the remedy. Verify recall #D-0142-2025 with the FDA Drug before acting.
The recall
Keystone Industries issued this moderate-severity FDA Drug recall-CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing ves….
- Moderate
- severity level
- Class II
- classification
- December 25, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0142-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0142-2025) was formally reported on December 25, 2024, with the manufacturer initiating the action on November 14, 2024. It is classified under Moderate severity (Class II), with a current status of Terminated. Keystone Industries is listed as the recalling firm, operating out of Gibbstown, NJ. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… Distribution data in the federal record shows the product reached: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.. 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
Unknown
Related Recalls
6
5 from same agency
Product description
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
Reason for recall
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0142-2025 |
| Date reported | December 25, 2024 |
| Date initiated | November 14, 2024 |
| Recalling firm | Keystone Industries |
| Firm location | Gibbstown, NJ |
| Affected scope | Not disclosed |
| Distribution | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. |
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-0142-2025) 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? ▼
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.. Recalled by Keystone Industries.
Why was this product recalled? ▼
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 25, 2024. Severity: Moderate. Recall number: D-0142-2025.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0142-2025) 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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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 December 25, 2024. 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.