Isotretinoin Capsules recall
FDA recall D-0446-2026 · initiated Jan 12, 2026
Teva Pharmaceuticals USA, Inc recalled Isotretinoin Capsules in Jan 2026 — an FDA Class II recall (D-0446-2026) because Superpotent and Subpotent.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Superpotent and Subpotent
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 8376 packages
Details
- 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).
- Recalling company
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- FL, OH, PR & MS
- Initiated
- Jan 12, 2026
- FDA report date
- Apr 15, 2026
Frequently asked
- Was Isotretinoin Capsules recalled?
- Teva Pharmaceuticals USA, Inc recalled Isotretinoin Capsules in Jan 2026 — an FDA Class II recall (D-0446-2026) because Superpotent and Subpotent. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Isotretinoin Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0446-2026 was: Superpotent and Subpotent
- Is a recalled Isotretinoin Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Isotretinoin Capsules are affected?
- Distributed: FL, OH, PR & MS. The recall covers these lots — Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0446-2026.