Aidarex Pharmaceuticals LLC recalls Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India.
Aidarex Pharmaceuticals recalls 5mg enalapril maleate bottles due to potential degradation products affecting safety. This recall applies to specific lot numbers and expiration dates.
Recall notice
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Contact the company & request your remedy
What happened, in plain English
Aidarex Pharmaceuticals is recalling enalapril maleate 5mg tablets (30-count) that were manufactured by Wockhardt Ltd. in India. The recall is due to stability issues where a degradation product may form, potentially affecting the medication's safety. Read more at govinfonow.com/recall/40393-aidarex-enalapril-5mg-recall-degradation-risk-in-rx-only-bottles.
Source Summary by GovInfoNow · govinfonow.com/recall/40393-aidarex-enalapril-5mg-recall-degradation-risk-in-rx-only-bottles · Updated October 6, 2026 · FDA enforcement record: FDA #D-0992-2018
Cite this page
“Aidarex Enalapril 5mg Recall: Degradation Risk in RX Only Bottles.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40393-aidarex-enalapril-5mg-recall-degradation-risk-in-rx-only-bottles. Based on FDA recall #D-0992-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0992-2018%22&limit=1).
Why it’s dangerous
The medication may degrade over time, forming a byproduct that could affect its safety. This degradation is linked to stability issues during commercial storage, though the exact risk to patients is not clearly described in the recall.
Who’s affected
Prescription patients who have received this specific enalapril product from Aidarex Pharmaceuticals. Those with medical conditions requiring this medication are most at risk.
How to tell if you have this one
Check for the product name 'Enalapril Maleate, USP 5MG, 30-count bottle' with the manufacturer Aidarex Pharmaceuticals. Look for specific lot numbers: 51904-2, 51904-3, 51904-5, 52885-2, or 53840-1, with expiration dates up to May 2018.
- Brand
Aidarex Pharmaceuticals- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Distributed Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| 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; Lots: 56698-1, EXP 1/31/2019; 56698-2, EXP 4/30/2019 | 11, 90-count bottles |
| D-0991-2018 | Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90; Lots: 51904-1, EXP: 01/31/2018; 51904-4, 52885-1, EXP: 03/31/2018; 52885-3, EXP: 04/30/2018; 52885-4,EXP: 05/28/2018; 53840-2,EXP: 5/28/2018; 53840-3, EXP:6/30/2018; 53840-4, EXP:8/31/2018; 56665-1, EXP: 01/31/2019; 58596-1, EXP: 05/28/2019. | 61, 90-count bottles |
| D-0992-2018 | Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30; 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. | 25, 30-count bottles |
What to do — step by step
Check Product Details
Identify the product by checking the lot number and expiration date on the bottle.
Questions people ask
Is this medication safe to use?
The recall states there may be stability issues, but the official notice does not specify if the medication is safe to use.
What should I do if I have this product?
The recall does not provide a remedy, so the official notice does not specify actions to take.
How can I confirm if my product is recalled?
Check the lot number and expiration date on the bottle; the recalled products have specific lot numbers and expiration dates listed in the recall.
Contact Aidarex Pharmaceuticals
We’ve drafted a message you can send Aidarex Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0992-2018 — Aidarex Pharmaceuticals Aidarex Pharmaceuticals Hello, I own a Aidarex Pharmaceuticals that is covered by recall D-0992-2018 from Aidarex Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0992-2018 (June 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0992-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.