Macleods Pharma recalls

10 official recalls and safety alerts involving Macleods Pharma since 2021-11, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Macleods Pharma or the relevant agency.

1. 2026-04-01
2. US
   Drugs & medicalClass II

   MACLEODS PHARMA USA, INC recalls Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ,…

   Subpotent Drug

   FDA · DrugMACLEODS PHARMA USA, INCNationwideOfficial notice →
3. 2024-05-22
4. US
   Drugs & medicalClass II

   MACLEODS PHARMA USA, INC recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma…

   Presence of foreign substance: plastic-like substance.

   FDA · DrugMACLEODS PHARMA USA, INCUSA NationwideOfficial notice →
5. 2023-01-25
6. US
   Drugs & medicalClass III

   MACLEODS PHARMA USA, INC recalls Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540;…

   Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

   FDA · DrugMACLEODS PHARMA USA, INCNationwide within United States and Puerto Rico.Official notice →
7. 2022-07-13
8. US
   Drugs & medicalClass II

   Macleods Pharma Usa Inc recalls Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536,…

   Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.

   FDA · DrugMacleods Pharma Usa IncDistributed Nationwide and Puerto Rico.Official notice →
9. 2022-07-06
10. US
    Drugs & medicalClass II

    Macleods Pharma Usa Inc recalls Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC #…

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    FDA · DrugMacleods Pharma Usa IncProduct was distributed nationwide.Official notice →
11. 2022-05-11
12. US
    Drugs & medicalClass II

    Macleods Pharma Usa Inc recalls 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…

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    FDA · DrugMacleods Pharma Usa IncProduct was distributed nationwide.Official notice →
13. 2022-04-13
14. US
    Drugs & medicalClass III

    Macleods Pharma Usa Inc recalls Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536,…

    FAILED CONTENT UNIFORMITY SPECIFICATIONS

    FDA · DrugMacleods Pharma Usa IncUSA NationwideOfficial notice →
15. 2022-03-09
16. US
    Drugs & medicalClass II

    Macleods Pharma Usa Inc recalls Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured…

    cGmp Deviations

    FDA · DrugMacleods Pharma Usa IncNationwide within the United StatesOfficial notice →
17. US
    Drugs & medicalClass II

    Macleods Pharma Usa Inc recalls Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc.,…

    cGMP deviations

    FDA · DrugMacleods Pharma Usa IncUSA NationwideOfficial notice →
18. 2021-11-03
19. US
    Drugs & medicalClass III

    MACLEODS PHARMA USA, INC recalls Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b)…

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

    FDA · DrugMACLEODS PHARMA USA, INCNationwide within the United StatesOfficial notice →