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Isotretinoin Capsules, USP, 40 mg
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DRUG RECALLMODERATE

Isotretinoin Capsules, USP, 40 mg

Teva is recalling 40 mg Isotretinoin Capsules due to potency issues.

What to do

Contact your healthcare provider or pharmacist to discuss alternative treatment options and return the affected medication to your pharmacy.

Recalled
Listed
Updated
Recall No.
D-0446-2026
Agency
FDA
Firm
Teva Pharmaceuticals USA, Inc
Recall ID
98275
Status
ONGOING

Why it was recalled

Teva Pharmaceuticals is recalling 40 mg Isotretinoin Capsules, USP, due to the product being superpotent and subpotent. The affected products are packaged in 10-count prescription packs.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Isotretinoin Capsules, USP

StrengthUPCRecall #
40 mg100075305, 100075512, 100076103D-0446-2026
30 mg100055426, 100071518, 100072450D-0445-2026

Where it was sold

Distributed in Florida, Mississippi, and Ohio.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other recent recalls from Teva Pharmaceuticals USA, Inc

All recalls from Teva Pharmaceuticals USA, Inc

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification