RecallRadar

FDA Drug recall D-0520-2022

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

On 2022-02-09 the FDA classified a Class II recall of Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02 by Teva Pharmaceuticals Usa, citing failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0520-2022
ClassificationClass II
Statusterminated
Initiated2022-01-10
Published2022-02-09
Last updated2026-09-13 11:52 UTC
CompanyTeva Pharmaceuticals Usa
DistributionUS

Product

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

Reason

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

Identifiers

code_infoLot #: 100022970, Exp. 08/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0520-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.