Harvard Drug Group recalls

12 official recalls and safety alerts involving Harvard Drug Group since 2021-12, 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 Harvard Drug Group or the relevant agency.

1. 2026-07-01
2. US
   Drugs & medicalClass II

   The Harvard Drug Group LLC recalls Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR…

   Subpotent Drug

   FDA · DrugThe Harvard Drug Group LLCU.S. Nationwide.Official notice →
3. 2026-04-29
4. US
   Drugs & medicalClass II

   The Harvard Drug Group LLC recalls Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and…

   Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

   FDA · DrugThe Harvard Drug Group LLCNationwide in the USAOfficial notice →
5. 2026-04-22
6. US
   Drugs & medicalClass II

   The Harvard Drug Group LLC recalls Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by:…

   Failed Dissolution Specifications

   FDA · DrugThe Harvard Drug Group LLCUS Nationwide.Official notice →
7. 2026-03-11
8. US
   Drugs & medicalClass II

   The Harvard Drug Group LLC recalls Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major…

   Defective container; inadequately sealed blister packaging.

   FDA · DrugThe Harvard Drug Group LLCNationwide US.Official notice →
9. 2025-10-29
10. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC recalls Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals,…

    Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

    FDA · DrugThe Harvard Drug Group LLCUS Nationwide.Official notice →
11. 2025-07-09
12. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC recalls Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR…

    Defective container; blister packaging inadequately sealed.

    FDA · DrugThe Harvard Drug Group LLCNationwideOfficial notice →
13. 2023-07-05
14. US
    Drugs & medicalClass II

    The Harvard Drug Group recalls Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey…

    Packaging defect: blister packaging inadequately sealed.

    FDA · DrugThe Harvard Drug GroupNationwide in the U.S.Official notice →
15. 2023-05-17
16. US
    Drugs & medicalClass III

    The Harvard Drug Group recalls Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo…

    Product mixup: one foreign tablet found in product.

    FDA · DrugThe Harvard Drug GroupUSA NationwideOfficial notice →
17. 2023-03-08
18. US
    Drugs & medicalClass II

    The Harvard Drug Group recalls Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech…

    Packaging defect: observed packaging defect, blister packaging inadequately sealed.

    FDA · DrugThe Harvard Drug GroupDistributed Nationwide in the USAOfficial notice →
19. 2022-03-23
20. US
    Drugs & medicalClass II

    The Harvard Drug Group recalls hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS,…

    Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.

    FDA · DrugThe Harvard Drug GroupNationwide within USAOfficial notice →
21. 2022-03-16
22. US
    Drugs & medicalClass II

    The Harvard Drug Group recalls PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical…

    Failed Dissolution Specifications

    FDA · DrugThe Harvard Drug GroupNationwide within the United StatesOfficial notice →
23. 2021-12-29
24. US
    Drugs & medicalClass II

    The Harvard Drug Group recalls Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive,…

    Failed Impurities/Degradation Specifications

    FDA · DrugThe Harvard Drug GroupNationwide USAOfficial notice →