CLASS II Drug recall · Reported 13 Sep 2023 · FDA Enforcement Report
Capsaicin Cream 0.025%, External Analgesic Cream recalled by AVKARE
Avkare is recalling Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief. The recall was initiated on 11 Aug 2023 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-1147-2023
- FDA event ID
- 92868
- Recalling firm
- Avkare, Pulaski, TN
- Brand
- Capsaicin
- Manufacturer
- AvPAK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Aug 2023
- FDA classified
- 7 Sep 2023
- Reported
- 13 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 11 Aug 2023 | Recall initiated by company | |
| 7 Sep 2023 | Classified by FDA | +27 days |
| 13 Sep 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
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478
Where it was distributed
Affected product was distributed to nineteen (19) consignees within the united states.
Questions about this recall
Why was it recalled?
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Which lots are affected?
Lot # P22078; Exp. 11/30/2024
Where was it sold?
Affected product was distributed to nineteen (19) consignees 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 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.
Other products in this recall event
1 other product · FDA event 92868| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sodium Fluoride 1.1%, Sodium Fluoride Prescription Dental recalledSodium Flouride | Avkare | Other | TN |
More recalls from Avkare
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
Other Capsaicin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Parche Leon Pain Relieving Hot Patch, Camphor recalledParche Leon | Unexo Life Sciences Private | Manufacturing (CGMP) Deviations | Nationwide |