--- title: "MACLEODS PHARMA USA, INC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search MACLEODS PHARMA USA, INC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/macleods-pharma-usa-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # MACLEODS PHARMA USA, INC recall records **2** reported ongoing 17 records in this archive. Latest source date Feb 26, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Feb 26, 2026 FDA drug enforcement ### [Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd...](https://isitonrecall.com/recall/fda-drug-d-0403-2026-levothyroxine-sodium-tablets-usp-150-mcg-1000-tablets-bottle-rx-only-manufactured-for-macleods-pharm/) Subpotent Drug Class II Reported ongoing Distribution: Nationwide [Official source for Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleod...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0403-2026%22) May 7, 2024 FDA drug enforcement ### [Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured ...](https://isitonrecall.com/recall/fda-drug-d-0498-2024-losartan-potassium-and-hydrochlorothiazide-tablets-usp-50mg-12-5-mg-1000-count-bottle-rx-only-manufa/) Presence of foreign substance: plastic-like substance. Class II Reported ongoing Distribution: USA Nationwide [Official source for Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0498-2024%22) Jan 5, 2023 FDA drug enforcement ### [Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Bad...](https://isitonrecall.com/recall/fda-drug-d-0162-2023-levofloxacin-tablets-usp-500-mg-50-count-bottles-rx-only-manufactured-for-macleods-pharma-usa-inc-pr/) Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles. Class III Reported terminated Distribution: Nationwide within United States and Puerto Rico. [Official source for Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma US...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0162-2023%22) Jun 16, 2022 FDA drug enforcement ### [Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical...](https://isitonrecall.com/recall/fda-drug-d-1174-2022-eszopiclone-tablets-usp-1-mg-packaged-in-30-count-bottles-rx-only-manufactured-for-macleods-pharma-u/) Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles. Class II Reported terminated Distribution: Distributed Nationwide and Puerto Rico. [Official source for Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1174-2022%22) Jun 10, 2022 FDA drug enforcement ### [Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA,...](https://isitonrecall.com/recall/fda-drug-d-1164-2022-losartan-potassium-hydrochlorothiazide-tablets-100-mg-25-mg-30-90-1000-count-ndc-33342-052-07-ndc-33/) CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Reported terminated Distribution: Product was distributed nationwide. [Official source for Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-05...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1164-2022%22) Apr 15, 2022 FDA drug enforcement ### [Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro,...](https://isitonrecall.com/recall/fda-drug-d-0832-2022-losartan-potassium-tablets-usp-25-mg-a-90-count-bottles-ndc-33342-044-10-b-1000-count-bottles-ndc-33/) CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Reported terminated Distribution: Product was distributed nationwide. [Official source for Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count b...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0832-2022%22) Apr 15, 2022 FDA drug enforcement ### [Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, ...](https://isitonrecall.com/recall/fda-drug-d-0833-2022-losartan-potassium-tablets-usp-50-mg-a-30-count-bottles-ndc-33342-045-07-b-90-count-bottles-ndc-3334/) CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Reported terminated Distribution: Product was distributed nationwide. [Official source for Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bot...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0833-2022%22) Apr 15, 2022 FDA drug enforcement ### [Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only,...](https://isitonrecall.com/recall/fda-drug-d-0834-2022-losartan-potassium-tablets-usp-100-mg-a-30-count-bottles-ndc-33342-046-07-b-90-count-bottles-ndc-333/) CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Reported terminated Distribution: Product was distributed nationwide. [Official source for Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bo...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0834-2022%22) Apr 15, 2022 FDA drug enforcement ### [Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (ND...](https://isitonrecall.com/recall/fda-drug-d-0835-2022-losartan-potassium-hydrochlorothiazide-tablets-usp-50-mg-12-5-mg-a-30-count-bottles-ndc-33342-050-07/) CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Reported terminated Distribution: Product was distributed nationwide. [Official source for Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 3...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0835-2022%22) Apr 15, 2022 FDA drug enforcement ### [Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC...](https://isitonrecall.com/recall/fda-drug-d-0836-2022-losartan-potassium-hydrochlorothiazide-tablets-usp-100-mg-25-mg-a-30-count-bottles-ndc-33342-052-07/) CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Reported terminated Distribution: Product was distributed nationwide. [Official source for Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0836-2022%22) Apr 15, 2022 FDA drug enforcement ### [Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (N...](https://isitonrecall.com/recall/fda-drug-d-0837-2022-losartan-potassium-hydrochlorothiazide-tablets-usp-100-mg-12-5-mg-a-30-count-bottles-ndc-33342-051-0/) CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Reported terminated Distribution: Product was distributed nationwide. [Official source for Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0837-2022%22) Mar 10, 2022 FDA drug enforcement ### [Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAd...](https://isitonrecall.com/recall/fda-drug-d-0762-2022-risedronate-sodium-tablets-usp-5-mg-rx-only-30-count-bottle-manufactured-for-macleods-pharma-usa-pla/) FAILED CONTENT UNIFORMITY SPECIFICATIONS Class III Reported terminated Distribution: USA Nationwide [Official source for Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharm...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0762-2022%22) Feb 16, 2022 FDA drug enforcement ### [Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Badd...](https://isitonrecall.com/recall/fda-drug-d-0639-2022-olanzapine-tablets-usp-10-mg-30-count-bottles-rx-only-manufactured-for-macleods-pharma-usa-inc-plain/) cGmp Deviations Class II Reported terminated Distribution: Nationwide within the United States [Official source for Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA ,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0639-2022%22) Feb 15, 2022 FDA drug enforcement ### [Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleod...](https://isitonrecall.com/recall/fda-drug-d-0632-2022-amlodipine-and-olmesartan-medoxomil-tablets-10-mg-20-mg-30-count-bottles-rx-only-manufactured-for-ma/) cGMP deviations Class II Reported terminated Distribution: USA Nationwide [Official source for Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufacture...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0632-2022%22) Oct 18, 2021 FDA drug enforcement ### [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 ...](https://isitonrecall.com/recall/fda-drug-d-0078-2022-rizatriptan-benzoate-film-coated-tablets-10-mg-packaged-in-a-12-tablets-2x6-unit-dose-tablets-bliste/) Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. Class III Reported terminated Distribution: Nationwide within the United States [Official source for Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0078-2022%22) Oct 18, 2021 FDA drug enforcement ### [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 08...](https://isitonrecall.com/recall/fda-drug-d-0079-2022-rizatriptan-benzoate-orally-disintegrating-tablets-5mg-12-tablets-2-x-6-unit-dose-tablets-blister-pa/) Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. Class III Reported terminated Distribution: Nationwide within the United States [Official source for Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blis...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0079-2022%22) Oct 18, 2021 FDA drug enforcement ### [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 0...](https://isitonrecall.com/recall/fda-drug-d-0080-2022-rizatriptan-benzoate-orally-disintegrating-tablets-10mg-18-tablets-3-x-6-unit-dose-tablets-blister-p/) Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. Class III Reported terminated Distribution: Nationwide within the United States [Official source for Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Bli...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0080-2022%22) ## Reasons in these listed records - Subpotent Drug - Presence of foreign substance: plastic-like substance. - Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles. - Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles. These examples come from this result page and are not a ranking of every recall reason. ## Checking MACLEODS PHARMA USA, INC ### Is there a recall on macleods pharma usa, inc right now? This archive contains 17 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search MACLEODS PHARMA USA, INC](https://isitonrecall.com/check/?q=MACLEODS%20PHARMA%20USA%2C%20INC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)