Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs
Summary
The FDA issued a Class II for Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, ND by Teva Pharmaceuticals USA, Inc. Reason: Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin.
Details
Source
Drug Recall
External ID
D-0521-2026
Action Date
2026-04-29
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lots#: 100067507, 100067508, Exp 07/31/2026
Quantity Affected: 5,101 cartons
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Distribution
Nationwide in the USA, Puerto Rico and Virgin Islands
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-06
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 82 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Teva Pharmaceuticals USA, Inc has 50 FDA actions in our database, including 50 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA, Inc have FDA actions?
Teva Pharmaceuticals USA, Inc has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0521-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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