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Drug FDA Class II Ongoing Sub/super-potent

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).

Teva Pharmaceuticals USA, Inc Published Apr 15, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Teva Pharmaceuticals USA, Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Superpotent and Subpotent

Hazards

Superpotency · primarySubpotency

Affected products (1)

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).

ISOTRETINOIN · 8376 packages

NDC: 0591-2433, 0591-2434, 0591-2451, 0591-2435, 0591-2501, 0591-2436, 0591-2433-45, 0591-2433-15, 0591-2434-45, 0591-2434-15, 0591-2451-45, 0591-2451-15, 0591-2435-45, 0591-2435-15, 0591-2501-45, 0591-2501-15, 0591-2436-45, 0591-2436-15
Lot codes: 100075305
Code info: Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .

Affected areas

FloridaMississippiOhioPuerto Rico

Timeline

  1. Initiated
    Jan 12, 2026
  2. Published
    Apr 15, 2026
Recall number
D-0446-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.