FDAClass IIJune 29, 2022

Tretinoin Capsules recall: Failed Dissolution

Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.

Why was Tretinoin Capsules recalled?

Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.

What should I do if I have this product?

Review the official FDA enforcement record for current 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 #s: 100022971, Exp. 08/2022; 100022972, Exp. 05/2023; 100028920, Exp. 09/2023

Product
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Recalling firm
Teva Pharmaceuticals USA Inc
Quantity
4941 bottles
Distribution
Nationwide in the U.S.
Recall date
June 29, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls