CLASS II Drug recall · Reported 5 Jul 2023 · FDA Enforcement Report
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose Tablets recalled
The Harvard Drug Group is recalling Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose Tablets, distributed nationwide in the US. The recall was initiated on 16 Jun 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0878-2023
- FDA event ID
- 92524
- Recalling firm
- The Harvard Drug Group, La Vergne, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2023
- FDA classified
- 26 Jun 2023
- Reported
- 5 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 16 Jun 2023 | Recall initiated by company | |
| 26 Jun 2023 | Classified by FDA | +10 days |
| 5 Jul 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packaging defect: blister packaging inadequately sealed.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Packaging defect: blister packaging inadequately sealed.
Which lots are affected?
Lot #: M04343, Exp. 04/2024
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
Other Tramadol recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP, 50 mg recalled | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP 50 mg recalledTramadol Hydrochloride | Rubicon Research Private | Other | Nationwide |
| Drug | CLASS II | TraMADol HCl, Packaged as (a) recalled by RemedyRepack | RemedyRepack | Packaging Defects | Nationwide |
| Drug | CLASS II | Tramadol Hydrochloride Tablets USP 100mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Tramadol Hydrochloride Tablets, USP, 50 mg recalled | Golden State Medical Supply | Packaging Defects | Nationwide |