Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Rizatriptan Benzoate Film Coated Tablets Recalled by MACLEODS PHARMA USA, INC Due to Out-of-specification test results obtained in Organic Impurities test...

Date: October 18, 2021
Company: MACLEODS PHARMA USA, 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 MACLEODS PHARMA USA, INC directly.

Affected Products

Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA

Quantity: 135,082 Blister Packs/2,431,476 tablets

Why Was This Recalled?

Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About MACLEODS PHARMA USA, INC

MACLEODS PHARMA USA, INC has 5 total recalls tracked by RecallDetector.

Related Recalls

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