CLASS II Drug recall · Reported 1 Aug 2012 · FDA Enforcement Report
Dent's Extra Strength Toothache Gum, (benzocaine 20%) recalled
Grandpa Brands is recalling Dent's Extra Strength Toothache Gum, (benzocaine 20%), distributed nationwide in the US. The recall was initiated on 9 May 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1425-2012
- FDA event ID
- 61838
- Recalling firm
- Grandpa Brands, Erlanger, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 May 2012
- FDA classified
- 24 Jul 2012
- Reported
- 1 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 9 May 2012 | Recall initiated by company | |
| 24 Jul 2012 | Classified by FDA | +76 days |
| 1 Aug 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent; benzocaine
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Superpotent; benzocaine
Which lots are affected?
Lot #s C2501 & B2111
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.