CLASS III Drug recall · Reported 15 Mar 2023 · FDA Enforcement Report
Dibucaine 1% Hemorrhoidal Ointment (28 gm) recalled by Akron Pharma
Akron Pharma is recalling Dibucaine 1% Hemorrhoidal Ointment (28 gm), distributed nationwide in the US. The recall was initiated on 17 Feb 2023 and the FDA has classified it as Class III.
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-0454-2023
- FDA event ID
- 91785
- Recalling firm
- Akron Pharma, Fairfield, NJ
- Brand
- Dibucaine
- Manufacturer
- Akron Pharma Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Feb 2023
- FDA classified
- 9 Mar 2023
- Reported
- 15 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 17 Feb 2023 | Recall initiated by company | |
| 9 Mar 2023 | Classified by FDA | +20 days |
| 15 Mar 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Product as listed by the FDA
DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date
Which lots are affected?
Lot #: 2206016, Exp. date 05/2024
Where was it sold?
Nationwide within the United States
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Akron Pharma
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Acetaminophen Extra Strength 500 mg per, Akron Pharma recalled | Akron Pharma | Other | Nationwide |
| Drug | CLASS III | Acetaminophen Extra Strength 500 mg per, Akron Pharma, Inc. recalled | Akron Pharma | Other | Nationwide |
| Drug | CLASS III | Diphenhydramine HCl 25 mg per, Akron Pharma recalled | Akron Pharma | Other | Nationwide |
| Drug | CLASS III | Acetaminophen Regular Strength, 325 mg per, Akron Pharma recalled | Akron Pharma | Other | Nationwide |
| Drug | CLASS III | Diphenhydramine HCl 50 mg per, Akron Pharma recalled | Akron Pharma | Other | Nationwide |
Other Dibucaine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment 28gm recalledDibucaine Topical Anesthetic 1% Hemorrhoidal | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |