---
title: "Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manuf... — FDA record D-0446-2026 | Is It on Recall"
description: "Superpotent and Subpotent"
url: https://isitonrecall.com/recall/fda-drug-d-0446-2026-isotretinoin-capsules-usp-40-mg-10-count-prescription-pacs-rx-only-manufactured-for-teva-pharmaceuti/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, I... — FDA record D-0446-2026

Reported ongoing

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 12, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
- **Reason**: Superpotent and Subpotent
- **Classification**: Class II
- **Recalling firm**: Teva Pharmaceuticals USA, Inc
- **Quantity**: 8376 packages
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0446-2026

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0446-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 . |

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

## Distribution

FL, OH, PR & MS

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

- [Florida](https://isitonrecall.com/state/florida/)
- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [Ohio](https://isitonrecall.com/state/ohio/)

## Dates in the source

- **Report date**: Apr 15, 2026
- **Recall initiation date**: Jan 12, 2026
- **Center classification date**: Apr 8, 2026

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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0446-2026%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Teva Pharmaceuticals USA Inc records](https://isitonrecall.com/brand/teva-pharmaceuticals-usa-inc/)