FDA Drug recall D-0915-2018
Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American…
- FDA Drug
- Class III
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class III recall of Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American… by American Health Packaging, citing failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0915-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-06-25 |
| Published | 2018-07-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Health Packaging |
| Distribution | n/a |
Product
Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]
Reason
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Identifiers
| code_info | Lot# 166023 - Exp. 11/30/18 (232 units). Lot# 168467 - Exp. 2/28/19 (1053 units). |
|---|
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 American Health Packaging
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FDA Drug · Class III · 2026-09-09 · American Health Packaging - Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton,…
FDA Drug · Class III · 2022-05-25 · American Health Packaging - Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugi…
FDA Drug · Class III · 2022-05-04 · American Health Packaging - Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only…
FDA Drug · Class II · 2022-03-16 · American Health Packaging
All American Health Packaging recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0915-2018%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.