FDAClass IIApril 17, 2024

Isotretinoin Capsules recall: Superpotent

Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ…

Why was Isotretinoin Capsules recalled?

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 100044259, Exp 06/30/2025.

Product
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ…
Recalling firm
Teva Pharmaceuticals USA, Inc
Quantity
5,304 3x10-cartons
Distribution
Nationwide in the USA
Recall date
April 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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