Use caution Drug recall · FDA · Published June 16, 2023

Harvard Drug Group Recalls Tramadol Tablets Due to Packaging Defect

The Harvard Drug Group is recalling Tramadol Hydrochloride Tablets, USP 50 mg due to blister packaging that may be inadequately sealed.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0878-2023Drug The Harvard Drug Group ›

Use caution until it’s fixed

Packaging defect: blister packaging inadequately sealed.

Take action

Contact the company

Recalling firmThe Harvard Drug Group341 Mason Rd · La Vergne, TN 37086-3606

✎ GovInfoNow plain-language explainer

The Harvard Drug Group is recalling a specific lot of Tramadol Hydrochloride Tablets, USP 50 mg because the unit-dose blister packaging was found to be inadequately sealed. This defect affects 3,876 cartons distributed nationwide in the U.S. The record does not specify what consumers should do with the product or provide a remedy. Read more at govinfonow.com/recall/33407-harvard-drug-group-recalls-tramadol-tablets-due-to-packaging-defect.

Source Summary by GovInfoNow · govinfonow.com/recall/33407-harvard-drug-group-recalls-tramadol-tablets-due-to-packaging-defect · Updated October 9, 2026 · FDA enforcement record: FDA #D-0878-2023

Cite this page

“Harvard Drug Group Recalls Tramadol Tablets Due to Packaging Defect.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/33407-harvard-drug-group-recalls-tramadol-tablets-due-to-packaging-defect. Based on FDA recall #D-0878-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0878-2023%22&limit=1).

The Harvard Drug Group voluntarily recalled Tramadol Hydrochloride Tablets, USP 50 mg due to blister packaging defects, according to the FDA on June 16, 2023.

How to tell if you have it

Tramadol Hydrochloride Tablets, USP 50 mg
Unit Dose 100-Count Tablets Rx only
Manufactured by: Sun Pharmaceutical Industries Ltd.
NDC 0904-7179-61
Lot #: M04343
Exp. 04/2024

The hazard

The recall addresses a packaging defect where the blister packaging was inadequately sealed, according to the FDA.

Context

GovInfoNow's records show The Harvard Drug Group has 20 other recalls on record since July 15, 2016. Other recent recalls of similar products include a Midodrine tablet recall due to defective packaging (Feb. 17, 2026) and an Amneal tramadol recall for NDSRI impurity risk (March 19, 2026).

How to tell if you have this one

Check if you have Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only. Look for NDC 0904-7179-61 and Lot # M04343 with an expiration date of 04/2024. The product was manufactured by Sun Pharmaceutical Industries Ltd. in India and distributed by The Harvard Drug Group, Sun Pharmaceutical Industries, Inc., or Major Pharmaceuticals.

Brand
The Harvard Drug Group
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Verify if your Tramadol Hydrochloride Tablets match NDC 0904-7179-61 and Lot # M04343 with an expiration date of 04/2024.
Contact Your Pharmacy
Reach out to the pharmacy where you filled your prescription to inquire about the recall and next steps for replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

Jun 16, 2023Firm started the recall
Jun 26, 2023FDA classified it Class II
Jul 5, 2023Published in FDA’s Enforcement Report
Apr 30, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/33407-harvard-drug-group-recalls-tramadol-tablets-due-to-packaging-defect">Harvard Drug Group Recalls Tramadol Tablets Due to Packaging Defect (GovInfoNow)</a>

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-0878-2023 (June 16, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0878-2023 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.