FDA Drug recall D-0055-2018
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manu…
- FDA Drug
- Class II
- terminated
- Published 2017-11-08
On 2017-11-08 the FDA classified a Class II recall of Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manu… by Avkare, citing failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0055-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-06 |
| Published | 2017-11-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Avkare |
| Distribution | US |
Product
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
Reason
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Identifiers
| code_info | Lot: 18103 Exp. 11/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Avkare
- Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com…
FDA Drug · Class II · 2026-03-04 · Avkare - Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478
FDA Drug · Class II · 2026-01-14 · Avkare - Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister c…
FDA Drug · Class II · 2025-10-15 · Avkare - chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 3847…
FDA Drug · Class II · 2025-09-17 · Avkare - chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 384…
FDA Drug · Class II · 2025-09-17 · Avkare
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0055-2018%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.