D-0439-2024 Class II Ongoing
FDA drug recall D-0439-2024 was initiated by Teva Pharmaceuticals USA, Inc on Mar 28, 2024 and is designated Class II. Reason for recall: Superpotent Drug: The 3-month stability result for assay was found to be above specification limit The recall status is ongoing. Affected quantity: 5,304 3x10-cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 17, 2024
- Initiation Date
- Mar 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,304 3x10-cartons
Product Description
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Reason for Recall
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 100044259, Exp 06/30/2025.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0439-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026