CLASS III Drug recall · Reported 26 Jun 2019 · FDA Enforcement Report
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) recalled
Teligent Pharma is recalling Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) (, distributed nationwide in the US. The recall was initiated on 20 May 2019 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-1391-2019
- FDA event ID
- 82983
- Recalling firm
- Teligent Pharma, Buena, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 May 2019
- FDA classified
- 14 Jun 2019
- Reported
- 26 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 20 May 2019 | Recall initiated by company | |
| 14 Jun 2019 | Classified by FDA | +25 days |
| 26 Jun 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
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
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot 11852, exp date 08/2020
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 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 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 |
Other Betamethasone Dipropionate recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Betamethasone Dipropionate Cream USP, 0.05% tube recalledBetamethasone Dipropionate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) recalled | McKesson | Potency & Assay | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented) recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Lotion USP, 0.05% (Augmented) recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) recalled | Teligent Pharma | Potency & Assay | Nationwide |