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Drug FDA Class II Ongoing Sub/super-potent

Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (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 and Subpotency · primary

Affected products (1)

Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).

ISOTRETINOIN · 21984 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: 100055426
Code info: Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027

Affected areas

FloridaMississippiOhioPuerto Rico

Timeline

  1. Initiated
    Jan 12, 2026
  2. Published
    Apr 15, 2026
Recall number
D-0445-2026
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.