CLASS II Drug recall · Reported 9 Feb 2022 · FDA Enforcement Report
Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals U
Teva Pharmaceuticals USA is recalling Tretinoin Capsules, 10 mg, distributed nationwide in the US. The recall was initiated on 10 Jan 2022 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-0520-2022
- FDA event ID
- 89385
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2022
- FDA classified
- 2 Feb 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 10 Jan 2022 | Recall initiated by company | |
| 2 Feb 2022 | Classified by FDA | +23 days |
| 9 Feb 2022 | 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
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
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
Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
Where it was distributed
nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Which lots are affected?
Lot #: 100022970, Exp. 08/2022
Where was it sold?
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.
More recalls from Teva Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Tretinoin recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals USA | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm recalled | The Medicine Shoppe Pharmacy | Other | FL |
| Drug | CLASS II | Tretinoin 0.02% In Oil Free Cream recalled by Synergy Rx | Synergy Rx | Sterility | Nationwide |
| Drug | CLASS II | Tretinoin Cream in all strengths including recalled by Synergy Rx | Synergy Rx | Sterility | Nationwide |