FDA DrugsClass II
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescript...
Published: March 11, 2026Recall ID: D-0399-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Dissolution Specifications
Product Description & Identification
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
Additional Source Details
| Field | Value |
|---|---|
| City | Morgantown |
| State | WV |
| 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 | 404058 |
| Openfda › Rxcui › 6 | 404061 |
| Openfda › Rxcui › 7 | 404064 |
| Openfda › Rxcui › 8 | 2711694 |
| Openfda › Spl id | 8105505f-9df6-4bc4-b201-7281a2d3af00 |
| Openfda › Brand name | AMNESTEEM |
| Openfda › Spl set id | b2cb63c9-f825-4991-9a2c-6260f1bbcc2c |
| Openfda › Package ndc › 1 | 0378-6611-85 |
| Openfda › Package ndc › 2 | 0378-6611-93 |
| Openfda › Package ndc › 3 | 0378-6612-85 |
| Openfda › Package ndc › 4 | 0378-6612-93 |
| Openfda › Package ndc › 5 | 0378-6613-85 |
| Openfda › Package ndc › 6 | 0378-6613-93 |
| Openfda › Package ndc › 7 | 0378-6614-85 |
| Openfda › Package ndc › 8 | 0378-6614-93 |
| Openfda › Product ndc › 1 | 0378-6611 |
| Openfda › Product ndc › 2 | 0378-6612 |
| Openfda › Product ndc › 3 | 0378-6613 |
| Openfda › Product ndc › 4 | 0378-6614 |
| 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 | Mylan Pharmaceuticals Inc. |
| Openfda › Application number | ANDA075945 |
| Openfda › Is original packager | true |
| Event id | 98477 |
| Address 1 | 1311 Pineview Dr |
| Address 2 | N/A |
| Code info | Lot #: 3116110, 3116130, Exp. Date 07/2026 |
| Postal code | 26505-3276 |
| Report date | 20260311 |
| Product type | Drugs |
| Product quantity | 34850 blister packs |
| Reason for recall | Failed Dissolution Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260224 |
| Initial firm notification | Letter |
| Center classification date | 20260319 |
Overview
- Recalling FirmMYLAN PHARMACEUTICALS INC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States