Claravis (isotretinoin capsule recall
Teva Pharmaceuticals USA, Inc recalled Claravis (isotretinoin capsule on April 29, 2026 because of failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin. It was sold nationwide.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
What's recalled
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.
Quantity: 5,101 cartons
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Nationwide in the USA, Puerto Rico and Virgin Islands - Status
- Ongoing
- Recall number
- D-0521-2026
- Source
- U.S. Food and Drug Administration
More drugs recalls
· Sterling Pharmaceutical Services LLCAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCClear Eyes Redness Relief
· Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCLubricant Eye Drops-Cameron Pharmaceuticals
· Sterling Pharmaceutical Services LLCReliable -1 Laboratories
· Sterling Pharmaceutical Services LLC