CLASS II ONGOING Drug recall · Reported 29 Apr 2026 · FDA Enforcement Report
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalled
Teva Pharmaceuticals USA is recalling Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a), distributed nationwide in the US. The recall was initiated on 6 Apr 2026 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-0521-2026
- FDA event ID
- 98730
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Claravis
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Apr 2026
- FDA classified
- 6 May 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 6 Apr 2026 | Recall initiated by company | |
| 29 Apr 2026 | Published in enforcement report | +23 days |
| 6 May 2026 | Classified by FDA | +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 Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
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
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Where it was distributed
Nationwide in the USA, Puerto Rico and Virgin Islands
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Which lots are affected?
Lots#: 100067507, 100067508, Exp 07/31/2026
Where was it sold?
Nationwide in the USA, Puerto Rico and Virgin Islands
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
All 280| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 | 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 |
| Drug | CLASS II | Clonidine Transdermal System, USP, 0.3 mg/day, supplied recalledClonidine Transdermal System | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | NJ |
Other Isotretinoin recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP 40mg blister packs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Isotretinoin Capsules, USP 10 mg recalled by Amneal PharmaceuticalsIsotretinoin | Amneal Pharmaceuticals | Potency & Assay | NY |