CLASS II Drug recall · Reported 25 Aug 2021 · FDA Enforcement Report
Econazole Nitrate Cream 1% bulk shippers recalled by Teligent Pharma
Teligent Pharma is recalling Econazole Nitrate Cream 1% bulk shippers, distributed nationwide in the US. The recall was initiated on 19 Jul 2021 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-0751-2021
- FDA event ID
- 88293
- Recalling firm
- Teligent Pharma, Buena, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jul 2021
- FDA classified
- 18 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 19 Jul 2021 | Recall initiated by company | |
| 18 Aug 2021 | Classified by FDA | +30 days |
| 25 Aug 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Correct Labeled Product Mispack
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
Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Correct Labeled Product Mispack
Which lots are affected?
Lot # 16630; Exp 03/2023
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.
Other products in this recall event
1 other product · FDA event 88293This product is part of a recall event; the main page for the event is Triamcinolone Acetonide Ointment recalled by Teligent Pharma.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Triamcinolone Acetonide Ointment recalled by Teligent Pharma | Teligent Pharma | Packaging Defects | Nationwide |
More recalls from Teligent Pharma
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Econazole Nitrate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide Topical Solution recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide Gel recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diflorasone Diacetate Ointment recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |