Food, drugs, devices › Aidarex Pharmaceuticals LLC
Drug recall: Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India.
Aidarex Pharmaceuticals LLC (Corona, CA) initiated this drug recall on 27 Jun 2018; FDA lists 3 product records under event 80397, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 29% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 4 Dec 2019. Initiation: voluntary: firm initiated. Aidarex Pharmaceuticals LLC has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aidarex Pharmaceuticals LLC, Corona, CA.
Reason for recall
"Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability."
Distribution
"Distributed Nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0990-2018 | Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90 | 11, 90-count bottles | Class III | Terminated | 1 Aug 2018 |
| D-0991-2018 | Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90 | 61, 90-count bottles | Class III | Terminated | 1 Aug 2018 |
| D-0992-2018 | Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30 | 25, 30-count bottles | Class III | Terminated | 1 Aug 2018 |
Context
Other enforcement events for Aidarex Pharmaceuticals LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Apr 2018 | Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 | Drug | Class III | 1 |
| 5 Sep 2017 | ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmac | Drug | Class III | 1 |
| 5 Sep 2017 | Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK- | Drug | Class III | 1 |
| 1 Jun 2016 | CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE | Drug | Class II | 1 |
| 1 Jun 2016 | CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 5 | Drug | Class III | 1 |
| 1 Jun 2016 | Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: | Drug | Class III | 1 |
| 22 May 2014 | Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceut | Drug | Class II | 1 |
All 8 events for Aidarex Pharmaceuticals LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed Nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Dec 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.