FDA DrugsClass II
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufact...
Published: April 15, 2026Recall ID: D-0446-2026Category: drugsCountry: US
Reason for Recall / Hazard
Superpotent and Subpotent
Product Description & Identification
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
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 | 1547561 |
| Openfda › Rxcui › 6 | 1547565 |
| Openfda › Spl id | 2f164fd8-4912-4149-9292-0dc2249a69a3 |
| Openfda › Brand name | ISOTRETINOIN |
| Openfda › Spl set id | 1cf11710-f966-4529-8e08-02175f588bca |
| Openfda › Package ndc › 1 | 0591-2433-45 |
| Openfda › Package ndc › 2 | 0591-2433-15 |
| Openfda › Package ndc › 3 | 0591-2434-45 |
| Openfda › Package ndc › 4 | 0591-2434-15 |
| Openfda › Package ndc › 5 | 0591-2451-45 |
| Openfda › Package ndc › 6 | 0591-2451-15 |
| Openfda › Package ndc › 7 | 0591-2435-45 |
| Openfda › Package ndc › 8 | 0591-2435-15 |
| Openfda › Package ndc › 9 | 0591-2501-45 |
| Openfda › Package ndc › 10 | 0591-2501-15 |
| Openfda › Package ndc › 11 | 0591-2436-45 |
| Openfda › Package ndc › 12 | 0591-2436-15 |
| Openfda › Product ndc › 1 | 0591-2433 |
| Openfda › Product ndc › 2 | 0591-2434 |
| Openfda › Product ndc › 3 | 0591-2451 |
| Openfda › Product ndc › 4 | 0591-2435 |
| Openfda › Product ndc › 5 | 0591-2501 |
| Openfda › Product ndc › 6 | 0591-2436 |
| 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 | Actavis Pharma, Inc. |
| Openfda › Application number | ANDA205063 |
| Openfda › Is original packager | true |
| Event id | 98275 |
| Address 1 | 400 Interpace Pkwy Bldg A |
| Code info | Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 . |
| Postal code | 07054-1120 |
| Report date | 20260415 |
| Product type | Drugs |
| Product quantity | 8376 packages |
| Reason for recall | Superpotent and Subpotent |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260112 |
| Initial firm notification | Letter |
| Center classification date | 20260408 |
Overview
- Recalling FirmTeva Pharmaceuticals USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionFL, OH, PR & MS