CLASS III Drug recall · Reported 1 Aug 2018 · FDA Enforcement Report
Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals
Aidarex Pharmaceuticals is recalling Enalapril Maleate, USP 5MG, distributed nationwide in the US. The recall was initiated on 27 Jun 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0992-2018
- FDA event ID
- 80397
- Recalling firm
- Aidarex Pharmaceuticals, Corona, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Jun 2018
- FDA classified
- 25 Jul 2018
- Reported
- 1 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 27 Jun 2018 | Recall initiated by company | |
| 25 Jul 2018 | Classified by FDA | +28 days |
| 1 Aug 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Which lots are affected?
Lots: 51904-2, EXP: 01/31/2018; 51904-3, EXP: 02/28/2018; 51904-5, EXP: 03/31/2018; 52885-2, EXP: 03/31/2018, 53840-1, EXP: 5/28/2018.
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 80397| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Enalapril Maleate, USP 2.5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS III | Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Aidarex Pharmaceuticals
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Enalapril Maleate, USP 2.5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Ferrous Sulfate recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Other | FL |
| Drug | CLASS III | Enalapril Maleate Tablets, USP, 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | FL |
| Drug | CLASS III | Phentermine, USP Capsules, 15 mg recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | CA, NV |
Other Enalapril recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Enalapril Maleate Tablets, USP, 20 mg recalled by JB Chemicals andEnalapril Maleate | JB Chemicals and Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |