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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.
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.
| Product | UPC | Recall # |
|---|---|---|
| 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). | 100075305, 100075512, 100076103 | D-0446-2026 |
| 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). | 100055426, 100071518, 100072450 | D-0445-2026 |
Where it was sold
Distributed in Florida, Mississippi, and Ohio.
Official source
Other recent recalls from Teva Pharmaceuticals USA, Inc
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification