Teva isotretinoin 40 mg capsules recalled as superpotent and subpotent
Teva is recalling three lots of Isotretinoin Capsules, USP, 40 mg because the product was found to be superpotent and subpotent. 8,376 packages are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for out-of-specification potency in both directions, which can under- or over-dose the patient, a risk of harm with no injuries reported.
Plain-English summary
Teva Pharmaceuticals USA, Inc is recalling Isotretinoin Capsules, USP, 40 mg, supplied in 10 count prescription packs, carton NDC 0591-2436-15 and blister pack NDC 0591-2436-45. The action covers 8,376 packages.
The stated reason is that the product was found to be superpotent and subpotent, meaning capsules fell outside the approved specification for the amount of active ingredient. The FDA classified the action as Class II.
Affected lots are 100075305 (exp 06/2027), 100075512 (exp 07/2027) and 100076103 (exp 07/2027). Distribution was to Florida, Ohio, Puerto Rico and Mississippi.
This is a prescription medicine. Patients should not stop taking a prescribed course without medical advice; anyone holding an affected lot should contact their pharmacy or prescriber about a replacement supply.
The recalled product
- Product
- ISOTRETINOIN (ISOTRETINOIN)
- Brand
- ISOTRETINOIN
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Oral capsule
- Affected units
- 8,376
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots 100075305 Exp date 06/2027
- 100075512
- Exp date 07/2027 & 100076103
- Exp date 07/2027 .
Distribution
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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