Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Pregabalin Capsules Recalled by SUN PHARMACEUTICAL INDUSTRIES INC Due to Failed Tablet/Capsule Specifications: Out of Specification results for...

Date: October 22, 2021
Company: SUN PHARMACEUTICAL INDUSTRIES INC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SUN PHARMACEUTICAL INDUSTRIES INC directly.

Affected Products

Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.

Quantity: 696 Bottles

Why Was This Recalled?

Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SUN PHARMACEUTICAL INDUSTRIES INC

SUN PHARMACEUTICAL INDUSTRIES INC has 86 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report