FDA Drug recall D-0510-2023
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA,…
- FDA Drug
- Class III
- terminated
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class III recall of Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA,… by Teva Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0510-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-03-27 |
| Published | 2023-04-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Reason
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Identifiers
| code_info | Lot # 3007556A, Exp 5/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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-0510-2023%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.