Isotretinoin Capsule
FDA Recall NDC 0591-2501
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Isotretinoin (NDC 0591-2501). A significant event, classified as Class II, was initiated on Jan 12, 2026 by Actavis Pharma, Inc.. The reported reason for this action was: "Superpotent and Subpotent"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Superpotent and Subpotent
Jan 12, 2026
Apr 15, 2026
8376 packages
Recall Profile & Regulatory Data
Event ID
98275
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, OH, PR & MS
Product Description
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).
Batch or Lot Expiration Information
Lot# Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
Affected Packages Involved in this Recall
0591-2433-45Product
0591-2433-15Product
0591-2434-45Product
0591-2434-15Product
0591-2451-45Product
0591-2451-15Product
0591-2435-45Product
0591-2435-15Product
0591-2501-45Product
0591-2501-15Product
0591-2436-45Product
0591-2436-15Product
Class II Ongoing
Superpotent and Subpotent
Jan 12, 2026
Apr 15, 2026
21984 packages
Recall Profile & Regulatory Data
Event ID
98275
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, OH, PR & MS
Product Description
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).
Batch or Lot Expiration Information
Lot# Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027
Affected Packages Involved in this Recall
0591-2433-45Product
0591-2433-15Product
0591-2434-45Product
0591-2434-15Product
0591-2451-45Product
0591-2451-15Product
0591-2435-45Product
0591-2435-15Product
0591-2501-45Product
0591-2501-15Product
0591-2436-45Product
0591-2436-15Product
Class II Ongoing
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Mar 28, 2024
Apr 17, 2024
5,304 3x10-cartons
Recall Profile & Regulatory Data
Event ID
94294
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# : 100044259, Exp 06/30/2025.
Affected Packages Involved in this Recall
0591-2433-45Product
0591-2433-15Product
0591-2434-45Product
0591-2434-15Product
0591-2451-45Product
0591-2451-15Product
0591-2435-45Product
0591-2435-15Product
0591-2501-45Product
0591-2501-15Product
0591-2436-45Product
0591-2436-15Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
