Medications & Supplements/Prescription Drugs

Pregabalin Capsules Recalled for Inconsistent Ingredient Specifications

Agency Publication Date: January 6, 2022

Summary

Sun Pharmaceutical Industries Inc. is recalling 696 bottles of Pregabalin Capsules (50 mg), a generic medication used to treat nerve pain and seizures. The recall was issued because the active ingredient failed tests for particle size distribution and bulk density, which can affect the medication's formulation. No injuries or adverse events have been reported in connection with this issue.

Risk

Inconsistencies in the physical properties of the active pharmaceutical ingredient, such as particle size and density, can lead to variations in how the drug is manufactured and how it performs. While no injuries have been reported, the product does not meet the necessary quality specifications.

What You Should Do

This recall affects Pregabalin Capsules, 50 mg, distributed by Sun Pharmaceutical Industries Inc. in 100-count bottles with NDC 47335-687-88.
Check your medication bottle for lot number DNC0432A with an expiration date of 01/2023.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Pregabalin Capsules (50 mg)

Variants: 50 mg, 100 count bottle, Rx only

Lot Numbers:

DNC0432A (Exp 01/2023)

NDC:

47335-687-88

Recall #: D-0361-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88927

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Pharmacies

Manufactured In: United States, India

Units Affected: 696 Bottles

Distributed To: Nationwide

Agency Last Updated: January 13, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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

What You Should Do

This recall affects Pregabalin Capsules, 50 mg, distributed by Sun Pharmaceutical Industries Inc. in 100-count bottles with NDC 47335-687-88.

Check your medication bottle for lot number DNC0432A with an expiration date of 01/2023.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.