The Recall Desk

Manufacturer

The Harvard Drug Group

45 recalls in our database name The Harvard Drug Group as the manufacturing or recalling firm.

What the numbers show

Total
45
Critical
1
Severe
24
Most recent
2023-07-05

Of the 45 recalls from The Harvard Drug Group we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 24 (53%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 45

  • ModerateFDA (Drugs)·D-0878-2023·2023-07-05

    Tramadol Hydrochloride Tablets Recalled Due to Inadequate Blister Packaging Seal

    The Harvard Drug Group recalls Tramadol Hydrochloride Tablets 50 mg nationwide due to inadequately sealed blister packaging. Affected lot M04343 (expiration 04/2024) may have compromised product integrity.

    Product
    Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0570-2023·2023-05-17

    Gabapentin tablets recalled due to product mixup with foreign tablet

    The Harvard Drug Group recalled 3,984 cartons of Gabapentin 600 mg tablets distributed nationwide due to a product mixup where one foreign tablet was found.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0432-2023·2023-03-08

    Carbidopa and Levodopa Tablets Recalled for Inadequate Blister Packaging Seal

    The Harvard Drug Group is recalling Carbidopa and Levodopa Tablets due to inadequate sealing of the blister packaging. The recall affects Lot M04145 distributed nationwide.

    Product
    Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0653-2022·2022-03-23

    hydrALAZINE HCl Tablets 10 mg Recalled for Failed Impurity Specifications

    The Harvard Drug Group is recalling hydrALAZINE HCl Tablets, USP, 10 mg due to failed impurity and degradation specifications detected during routine stability testing. The recall affects 5,953 cartons distributed nationwide.

    Product
    hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0649-2022·2022-03-16

    Paliperidone Extended-Release Tablets Recalled for Failed Dissolution

    The Harvard Drug Group is recalling 174 cartons of Paliperidone Extended-Release Tablets, 9 mg, nationwide due to failed dissolution specifications. The affected lots are N00522 (Exp. 09/2022) and N00618 (Exp. 11/2022).

    Product
    PALIPERIDONE — PALIPERIDONE (PALIPERIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0289-2022·2021-12-29

    Fexofenadine Hydrochloride Tablets 60 mg Recalled for Failed Impurities and Degradation Specifications

    The Harvard Drug Group is recalling Fexofenadine Hydrochloride Tablets, 60 mg, distributed by Major Pharmaceuticals nationwide due to failed impurities and degradation specifications. Affected lots are H00005, H00006, and H00007.

    Product
    Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0806-2021·2021-09-29

    Entacapone Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling Entacapone 200 mg tablets distributed in Colorado, Florida, Missouri, and Ohio due to failed dissolution specifications that may affect drug efficacy.

    Product
    ENTACAPONE — ENTACAPONE (ENTACAPONE)
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0807-2021·2021-09-29

    Carbamazepine 200mg Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling Carbamazepine 200mg tablets (Lot R01562, expiring 10/2022) distributed in North Carolina because they failed to meet required dissolution specifications, which may affect the drug's effectiveness.

    Product
    CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0652-2021·2021-07-21

    Nifedipine Extended-Release Tablets Recall for Failed Dissolution

    The Harvard Drug Group is recalling Nifedipine Extended-Release Tablets 30 mg due to failed dissolution specification discovered during routine stability testing. The affected lots were distributed in Ohio and New Jersey.

    Product
    NIFEDIPINE — NIFEDIPINE (NIFEDIPINE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0114-2021·2020-12-09

    Harvard Drug Group Recalls Aripiprazole Tablets for Dissolution Failure

    The Harvard Drug Group is recalling 841 cartons of Aripiprazole Tablets, 15 mg, because the product failed to meet dissolution specifications.

    Product
    Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1360-2020·2020-07-08

    Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    The Harvard Drug Group is recalling Metformin Hydrochloride Extended-Release Tablets due to potential NDMA impurity levels above established limits.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1262-2020·2020-05-20

    Memantine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failures

    The Harvard Drug Group is recalling 678 cartons of Memantine Hydrochloride Extended-Release Capsules due to low stage 3 dissolution results found during routine stability testing.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    6 states
  • LowFDA (Drugs)·D-0844-2020·2020-02-26

    Memantine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failure

    The Harvard Drug Group is recalling 246 cartons of Memantine Hydrochloride Extended-Release Capsules, 28mg, due to failed dissolution specifications observed during stability studies.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0013-2018·2017-10-25

    Alprazolam Tablets Recalled for Unknown Impurity

    The Harvard Drug Group is recalling Alprazolam Tablets, 0.25 mg, due to an out-of-specification result for an unknown impurity.

    Product
    Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laure
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3523-2017·2017-09-20

    Rugby Tri-vitamin Liquid Recalled for B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Tri-vitamin Liquid due to possible contamination with B. cepacia, which poses a risk of serious infection for vulnerable patients.

    Product
    Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3526-2017·2017-09-20

    Voluntary Recall of Major Ferrous Drops Due to B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major Ferrous Drops due to possible B. cepacia contamination, which poses a serious infection risk to vulnerable patients.

    Product
    Major Ferrous Drops, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3527-2017·2017-09-20

    Major Poly-Vita Drops Recalled for B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major Poly-Vita Drops due to possible B. cepacia contamination, which poses a serious infection risk to immunocompromised patients.

    Product
    Major Poly-Vita Drops, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3521-2017·2017-09-20

    Rugby Polyvitamin Liquid Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Polyvitamin Liquid due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3524-2017·2017-09-20

    Major CertaVite Liquid Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major CertaVite Liquid due to possible B. cepacia contamination, which poses a risk of serious infection to patients with compromised immune systems or chronic lung conditions.

    Product
    Major CertaVite Liquid, 8 oz. (236 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3522-2017·2017-09-20

    Rugby Polyvitamin Liquid Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Polyvitamin Liquid with Iron due to possible B. cepacia contamination, which poses a serious infection risk to vulnerable patients.

    Product
    Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide