FDA Drug recall D-0439-2024
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsipp…
- FDA Drug
- Class II
- ongoing
- Published 2024-04-17
On 2024-04-17 the FDA classified a Class II recall of Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsipp… by Teva Pharmaceuticals Usa, citing superpotent Drug: The 3-month stability result for assay was found to be above specification limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0439-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-28 |
| Published | 2024-04-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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
Reason
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Identifiers
| ndc | 0591-2433-45 |
|---|---|
| ndc | 0591-2433-15 |
| ndc | 0591-2434-45 |
| ndc | 0591-2434-15 |
| ndc | 0591-2451-45 |
| ndc | 0591-2451-15 |
| ndc | 0591-2435-45 |
| ndc | 0591-2435-15 |
| ndc | 0591-2501-45 |
| ndc | 0591-2501-15 |
| ndc | 0591-2436-45 |
| ndc | 0591-2436-15 |
| code_info | Lot #: 100044259, Exp 06/30/2025. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Teva Pharmaceuticals Usa
- Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054
FDA Drug · Class II · 2026-10-21 · Teva Pharmaceuticals Usa - traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manuf…
FDA Drug · Class II · 2026-09-09 · Teva Pharmaceuticals Usa - Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg stre…
FDA Drug · Class II · 2026-05-13 · Teva Pharmaceuticals Usa - Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60
FDA Drug · Class II · 2026-04-29 · Teva Pharmaceuticals Usa - Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis La…
FDA Drug · Class II · 2026-04-15 · Teva Pharmaceuticals Usa
All Teva Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0439-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.