Drug recall · FDA · Published October 18, 2021

MACLEODS PHARMA USA, INC recalls Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC

Macleods Pharma recalls 10mg Rizatriptan Benzoate Film Coated Tablets due to organic impurities found in testing. Affected lots expire 04/2024. No specific remedy provided in recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · How we make summaries

🇺🇸 FDA recall #D-0078-2022Drug Macleods Pharma ›

Recall notice

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

Take action

Contact the company & request your remedy

Recalling firmMACLEODS PHARMA USA, INC103 College Rd E Fl 2, N/A · Princeton, NJ 08540-6611

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Macleods Pharma is recalling 10mg Rizatriptan Benzoate Film Coated Tablets that tested positive for organic impurities. This could pose a health risk if taken as prescribed, though the recall doesn't specify a remedy. Read more at govinfonow.com/recall/35644-macleods-pharma-rizatriptan-tablets-recall-organic-impurities-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35644-macleods-pharma-rizatriptan-tablets-recall-organic-impurities-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0078-2022

Cite this page

“Macleods Pharma Rizatriptan Tablets Recall: Organic Impurities Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/35644-macleods-pharma-rizatriptan-tablets-recall-organic-impurities-risk. Based on FDA recall #D-0078-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0078-2022%22&limit=1).

Why it’s dangerous

The recall is based on test results showing organic impurities in the medication. These impurities could potentially cause health issues if the medication is taken as directed, though the exact risk level isn't specified in the recall notice.

Who’s affected

People who have the specific lot numbers of Rizatriptan tablets (NDC 33342-088-45 or 33342-088-41) with expiration dates up to April 2024. Those using prescription medication for migraines are most at risk.

How to tell if you have this one

Check for blister packs with 12 tablets (NDC 33342-088-45) or 18 tablets (NDC 33342-088-41) that were manufactured between Lot BRJ2112A and BRJ2114B and expire by April 2024.

Brand
Macleods Pharma
Category
Drug

FDA recall event · 3 products

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
Nationwide within the United States

Recall number	Product, codes & lots	Quantity	NDC
D-0078-2022	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; Lot #: BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024	135,082 Blister Packs/2,431,476 tablets	33342-087-07, 33342-087-46, 33342-087-12, 33342-087-52, 33342-087-50, 33342-087-72, 33342-087-02, 33342-087-45, 33342-087-41, 33342-088-07, 33342-088-46, 33342-088-12, 33342-088-52, 33342-088-50, 33342-088-72, 33342-088-02, 33342-088-45, 33342-088-41
D-0079-2022	Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41; Lot #: BRL2102A, BRL2103A, exp. date 04/2025	13,260 Blister Packs/238,680 tablets	33342-093-48, 33342-093-07, 33342-093-46, 33342-093-12, 33342-093-52, 33342-093-73, 33342-093-72, 33342-093-41, 33342-093-45, 33342-093-04, 33342-093-23, 33342-094-47, 33342-094-07, 33342-094-46, 33342-094-12, 33342-094-52, 33342-094-73, 33342-094-72, 33342-094-41, 33342-094-45, 33342-094-04, 33342-094-23
D-0080-2022	Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41; Lot #: BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, BRM2116A, exp. date 04/2025	643,800 Blister Packs /888,336 Tablets	33342-093-48, 33342-093-07, 33342-093-46, 33342-093-12, 33342-093-52, 33342-093-73, 33342-093-72, 33342-093-41, 33342-093-45, 33342-093-04, 33342-093-23, 33342-094-47, 33342-094-07, 33342-094-46, 33342-094-12, 33342-094-52, 33342-094-73, 33342-094-72, 33342-094-41, 33342-094-45, 33342-094-04, 33342-094-23

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the NDC codes 33342-088-45 or 33342-088-41 on the blister pack to confirm if your tablets are affected.

✎ GovInfoNow

Questions people ask

Why is this medication being recalled?

The recall is due to organic impurities found in testing, which could pose a health risk if taken as prescribed.

What should I do if I have these tablets?

The recall notice does not specify a remedy, so you should check with your healthcare provider for guidance.

Are these tablets safe to use?

The recall indicates potential health risks from organic impurities, but the exact risk level isn't specified in the notice.

Take action

Contact Macleods Pharma

We’ve drafted a message you can send Macleods Pharma to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0078-2022 — Macleods Pharma Macleods Pharma

Hello,

I own a Macleods Pharma that is covered by recall D-0078-2022 from Macleods Pharma.

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.

Similar recalls

Keep exploring

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-0078-2022 (October 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0078-2022 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 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.