Class II

Drug Recall: 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 05

Teva Pharmaceuticals USA, Inc · March 28, 2024

Reason for Recall

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

Product Description

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

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

5,304 3x10-cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0439-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.