Harvard Drug Group Recalls Doxycycline Hyclate Tablets Due to Dissolution Failure
The Harvard Drug Group is recalling specific lots of Doxycycline Hyclate Tablets, USP, 100 mg due to failed dissolution specifications at the end of shelf life.
Use caution until it’s fixed
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Contact the company
What happened, in plain English
The Harvard Drug Group has recalled Doxycycline Hyclate Tablets, USP, 100 mg because they failed dissolution specifications at the end of their shelf life. This means the medication may not release its active ingredient properly, potentially reducing its effectiveness. The recall affects 16,443 cartons distributed nationwide in the United States. Read more at govinfonow.com/recall/37108-harvard-drug-group-recalls-doxycycline-hyclate-tablets-due-to-dissolution.
Source Summary by GovInfoNow · govinfonow.com/recall/37108-harvard-drug-group-recalls-doxycycline-hyclate-tablets-due-to-dissolution · Updated October 11, 2026 · FDA enforcement record: FDA #D-1288-2020
Cite this page
“Harvard Drug Group Recalls Doxycycline Hyclate Tablets Due to Dissolution Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37108-harvard-drug-group-recalls-doxycycline-hyclate-tablets-due-to-dissolution. Based on FDA recall #D-1288-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1288-2020%22&limit=1).
Why it’s dangerous
The tablets failed dissolution testing at the 24-month time point, which is the end of their shelf life. This out-of-specification result indicates that the drug may not dissolve correctly in the body, leading to reduced potency and potentially inadequate treatment of the condition it is meant to address.
Who’s affected
Patients who have been prescribed Doxycycline Hyclate Tablets, USP, 100 mg from the specific lots listed below. Individuals relying on this medication for bacterial infections are at risk of receiving a product that may not work as intended.
How to tell if you have this one
Check your medication bottle for the following details: Brand: The Harvard Drug Group; Product: Doxycycline Hyclate Tablets, USP, 100 mg. Look for NDC numbers 0904-0430-04 or 0904-0430-06. Check the lot numbers and expiration dates: Lot R00828D (Exp. 08/2020), Lot R00732D (Exp. 05/2020), Lot R00783D (Exp. 06/2020), or Lot R00827D (Exp. 08/2020).
- Brand
The Harvard Drug Group- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Doxycycline Hyclate Tablets match the recalled lot numbers and expiration dates listed in the record.
Contact Your Pharmacist
If you have a recalled product, contact your pharmacist or healthcare provider to discuss replacing the medication or obtaining a refund.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How can I identify the correct NDC numbers?
Look for NDC 0904-0430-04 (3x10 unit dose cartons) or NDC 0904-0430-06 (5 x 10 unit dose carton).
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1288-2020 (May 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1288-2020 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.