CLASS II Drug recall · Reported 5 Jan 2022 · FDA Enforcement Report
Betamethasone Dipropionate Lotion USP, 0.05% (Augmented) recalled
Teligent Pharma is recalling Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), distributed nationwide in the US. The recall was initiated on 23 Aug 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-0297-2022
- FDA event ID
- 88550
- Recalling firm
- Teligent Pharma, Buena, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Aug 2021
- FDA classified
- 28 Dec 2021
- Reported
- 5 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 23 Aug 2021 | Recall initiated by company | |
| 28 Dec 2021 | Classified by FDA | +127 days |
| 5 Jan 2022 | 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
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
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 Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Which lots are affected?
Lot # 16569, Exp 9/2022
Where was it sold?
Distributed Nationwide in the USA
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.
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|---|---|---|---|---|---|
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
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| 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 III | Betamethasone Dipropionate Ointment 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 |