Drugs & medicalClass II

The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister…

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was…

Read the official notice →
Date
2025-09-17
Country
United States
Brand
Harvard Drug Group LLC dba Major Pharmaceuticals and…
Product
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only,…
Classification
Class II
Units
USA Nationwide.
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls

  1. 2025-10-15
  2. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only,…

    CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…NationwideOfficial notice →
  3. 2025-08-27
  4. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by…

    CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Product was distributed nationwide within the United States.Official notice →
  5. 2025-04-23
  6. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only,…

    CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide USAOfficial notice →
  7. 2025-04-09
  8. US
    Drugs & medicalClass III

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only,…

    Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the USAOfficial notice →
  9. 2025-02-26
  10. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The…

    Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide U.S. and Puerto ricoOfficial notice →
  11. 2025-02-12
  12. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10…

    Failed Dissolution Specifications.

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the USAOfficial notice →
All 15 Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls →

Other drugs & medical recalls in the United States

  1. 2025-09-17
  2. US
    Drugs & medicalClass II

    Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi,…

    CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

    FDA · DrugZydus Pharmaceuticals (USA) IncNationwide in the USAOfficial notice →
  3. US
    Drugs & medicalClass II

    Atlantic Management Resources Ltd. recalls Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581…

    cGMP violations

    FDA · DrugAtlantic Management Resources Ltd.Product was distributed via the internet.Official notice →
  4. US
  5. US
    Drugs & medicalClass II

    Zydus Pharmaceuticals (USA) Inc recalls Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by…

    Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.

    FDA · DrugZydus Pharmaceuticals (USA) IncMS, OH, LA, and Puerto RicoOfficial notice →
  6. US
  7. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical…

    CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

    FDA · DrugBreckenridge Pharmaceutical, Inc.AZ, IN, NJOfficial notice →
See all drugs & medical recalls →