FDA DrugsClass II
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, ND...
Published: April 29, 2026Recall ID: D-0521-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Parsippany |
| State | NJ |
| Openfda › Nui › 1 | N0000175607 |
| Openfda › Nui › 2 | M0018962 |
| Openfda › Unii | EH28UP18IF |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 197843 |
| Openfda › Rxcui › 2 | 197844 |
| Openfda › Rxcui › 3 | 197845 |
| Openfda › Rxcui › 4 | 403930 |
| Openfda › Rxcui › 5 | 404059 |
| Openfda › Rxcui › 6 | 404062 |
| Openfda › Rxcui › 7 | 404065 |
| Openfda › Rxcui › 8 | 643488 |
| Openfda › Spl id | a69dde5d-5585-4313-be43-02d11fec4c9f |
| Openfda › Brand name | CLARAVIS |
| Openfda › Spl set id | a31fd109-d0fd-4ab9-ba98-a3d64333c18d |
| Openfda › Package ndc › 1 | 0555-1054-60 |
| Openfda › Package ndc › 2 | 0555-1054-86 |
| Openfda › Package ndc › 3 | 0555-1054-56 |
| Openfda › Package ndc › 4 | 0555-1055-60 |
| Openfda › Package ndc › 5 | 0555-1055-86 |
| Openfda › Package ndc › 6 | 0555-1055-56 |
| Openfda › Package ndc › 7 | 0555-1056-60 |
| Openfda › Package ndc › 8 | 0555-1056-86 |
| Openfda › Package ndc › 9 | 0555-1057-60 |
| Openfda › Package ndc › 10 | 0555-1057-56 |
| Openfda › Package ndc › 11 | 0555-1057-86 |
| Openfda › Product ndc › 1 | 0555-1054 |
| Openfda › Product ndc › 2 | 0555-1055 |
| Openfda › Product ndc › 3 | 0555-1056 |
| Openfda › Product ndc › 4 | 0555-1057 |
| Openfda › Generic name | ISOTRETINOIN |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Retinoids [CS] |
| Openfda › Substance name | ISOTRETINOIN |
| Openfda › Pharm class epc | Retinoid [EPC] |
| Openfda › Manufacturer name | Teva Pharmaceuticals USA, Inc. |
| Openfda › Application number | ANDA076356 |
| Openfda › Is original packager | true |
| Event id | 98730 |
| Address 1 | 400 Interpace Pkwy Bldg A |
| Address 2 | N/A |
| Code info | Lots#: 100067507, 100067508, Exp 07/31/2026 |
| Postal code | 07054-1120 |
| Report date | 20260429 |
| Product type | Drugs |
| Product quantity | 5,101 cartons |
| Reason for recall | Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260406 |
| Initial firm notification | Letter |
| Center classification date | 20260506 |
Overview
- Recalling FirmTeva Pharmaceuticals USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA, Puerto Rico and Virgin Islands