Recall archive / FDA drug enforcement

Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555... — FDA record D-0520-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 10, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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.
Classification: Class II
Recalling firm: Teva Pharmaceuticals USA
Quantity: 1,175 Bottles
Agency-reported status: Terminated
Source record identifier: D-0520-2022

Open the official record

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Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot #: 100022970, Exp. 08/2022

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

nationwide in the USA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Feb 9, 2022
Recall initiation date: Jan 10, 2022
Center classification date: Feb 2, 2022
Termination date: Dec 21, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.