Medications & Supplements/Prescription Drugs

Aidarex Pharmaceuticals LLC: Enalapril Maleate Recalled for Impurity Degradation Concerns

Agency Publication Date: July 24, 2018

Summary

Aidarex Pharmaceuticals is recalling 97 bottles of Enalapril Maleate (2.5mg and 5mg), a blood pressure medication manufactured by Wockhardt Ltd. The recall was issued because the drug did not meet stability standards for a degradation byproduct called Enalapril Diketopiperazine during routine testing. Consumers should contact their healthcare provider or pharmacist regarding their medication, as using a product with out-of-specification degradation results may affect the drug's quality or safety.

Risk

The presence of degradation products exceeding approved limits means the medication may not maintain its intended chemical stability and quality over time. While the risk is categorized as low, impurities in prescription medications can potentially lead to reduced effectiveness or unintended side effects.

What You Should Do

Identify your medication by checking the NDC number and lot details on the bottle label. Affected 2.5mg 90-count bottles have NDC 33261-0977-90 and lots 56698-1 (Exp 1/31/2019) or 56698-2 (Exp 4/30/2019).
Affected 5mg 90-count bottles have NDC 33261-0693-90 and lots: 51904-1 (Exp 01/31/2018), 51904-4 or 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), or 58596-1 (Exp 05/28/2019).
Affected 5mg 30-count bottles have NDC 33261-0693-30 and 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), or 53840-1 (Exp 5/28/2018).
Contact your healthcare provider or pharmacist immediately to discuss continuing your treatment or obtaining a replacement prescription.
Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund.
Contact Aidarex Pharmaceuticals LLC at 595 N Smith Ave, Corona, California for further information regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

FDA Drug Recall Remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Enalapril Maleate, USP 2.5MG (90-count bottle)

Model:

NDC: 33261-0977-90

Recall #: D-0990-2018

Lot Numbers:

56698-1 (Exp 1/31/2019)

56698-2 (Exp 4/30/2019)

Date Ranges: Exp 1/31/2019, Exp 4/30/2019

Product: Enalapril Maleate, USP 5MG (90-count bottle)

Model:

NDC: 33261-0693-90

Recall #: D-0991-2018

Lot Numbers:

51904-1 (Exp: 01/31/2018)

51904-4 (Exp: 03/31/2018)

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)

Date Ranges: Exp: 01/31/2018, Exp: 03/31/2018, Exp: 04/30/2018, Exp: 05/28/2018, Exp: 6/30/2018, Exp: 8/31/2018, Exp: 01/31/2019, Exp: 05/28/2019

Product: Enalapril Maleate, USP 5MG (30-count bottle)

Model:

NDC: 33261-0693-30

Recall #: D-0992-2018

Lot Numbers:

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)

Date Ranges: Exp: 01/31/2018, Exp: 02/28/2018, Exp: 03/31/2018, Exp: 5/28/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80397

Status: Resolved

Manufacturer: Aidarex Pharmaceuticals LLC

Sold By: pharmacies

Manufactured In: United States, India

Units Affected: 3 products (11, 90-count bottles; 61, 90-count bottles; 25, 30-count bottles)

Distributed To: Nationwide

Agency Last Updated: July 25, 2018

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify your medication by checking the NDC number and lot details on the bottle label. Affected 2.5mg 90-count bottles have NDC 33261-0977-90 and lots 56698-1 (Exp 1/31/2019) or 56698-2 (Exp 4/30/2019).

Affected 5mg 90-count bottles have NDC 33261-0693-90 and lots: 51904-1 (Exp 01/31/2018), 51904-4 or 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), or 58596-1 (Exp 05/28/2019).

Affected 5mg 30-count bottles have NDC 33261-0693-30 and 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), or 53840-1 (Exp 5/28/2018).

Contact your healthcare provider or pharmacist immediately to discuss continuing your treatment or obtaining a replacement prescription.

Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund.

Contact Aidarex Pharmaceuticals LLC at 595 N Smith Ave, Corona, California for further information regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Affected Products

Product: Enalapril Maleate, USP 2.5MG (90-count bottle)

Model:

NDC: 33261-0977-90

Recall #: D-0990-2018

Lot Numbers:

56698-1 (Exp 1/31/2019)

56698-2 (Exp 4/30/2019)

Date Ranges: Exp 1/31/2019, Exp 4/30/2019

Product: Enalapril Maleate, USP 5MG (90-count bottle)

Model:

NDC: 33261-0693-90

Recall #: D-0991-2018

Lot Numbers:

51904-1 (Exp: 01/31/2018)

51904-4 (Exp: 03/31/2018)

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)

Date Ranges: Exp: 01/31/2018, Exp: 03/31/2018, Exp: 04/30/2018, Exp: 05/28/2018, Exp: 6/30/2018, Exp: 8/31/2018, Exp: 01/31/2019, Exp: 05/28/2019

Product: Enalapril Maleate, USP 5MG (30-count bottle)

Model:

NDC: 33261-0693-30

Recall #: D-0992-2018

Lot Numbers:

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)

Date Ranges: Exp: 01/31/2018, Exp: 02/28/2018, Exp: 03/31/2018, Exp: 5/28/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80397

Status: Resolved

Manufacturer: Aidarex Pharmaceuticals LLC

Sold By: pharmacies

Manufactured In: United States, India

Units Affected: 3 products (11, 90-count bottles; 61, 90-count bottles; 25, 30-count bottles)

Distributed To: Nationwide

Agency Last Updated: July 25, 2018