Isotretinoin Capsules recall
FDA recall D-0439-2024 · initiated Mar 28, 2024
Teva Pharmaceuticals USA, Inc recalled Isotretinoin Capsules in Mar 2024 — an FDA Class II recall (D-0439-2024) because Superpotent Drug: The 3-month stability result for assay was found to be above specification limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
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: 5,304 3x10-cartons
Details
- Product
- Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
- Recalling company
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Mar 28, 2024
- FDA report date
- Apr 17, 2024
Frequently asked
- Was Isotretinoin Capsules recalled?
- Teva Pharmaceuticals USA, Inc recalled Isotretinoin Capsules in Mar 2024 — an FDA Class II recall (D-0439-2024) because Superpotent Drug: The 3-month stability result for assay was found to be above specification limit. 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-0439-2024 was: Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
- 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: Nationwide in the USA. The recall covers these lots — Lot #: 100044259, Exp 06/30/2025.. 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-0439-2024.