CLASS III Drug recall · Reported 18 Apr 2018 · FDA Enforcement Report
Tramadol Hydrochloride recalled by Lake Erie Medical & Surgical
Lake Erie Medical & Surgical Supply is recalling Tramadol Hydrochloride, distributed in Florida, Virginia. The recall was initiated on 19 Mar 2018 and the FDA has classified it as Class III.
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-0626-2018
- FDA event ID
- 79640
- Recalling firm
- Lake Erie Medical & Surgical Supply, Holland, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Mar 2018
- FDA classified
- 11 Apr 2018
- Reported
- 18 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 19 Mar 2018 | Recall initiated by company | |
| 11 Apr 2018 | Classified by FDA | +23 days |
| 18 Apr 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Product as listed by the FDA
Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01
Where it was distributed
FL, VA
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date
Which lots are affected?
Lot # 116289, Exp. 09/20
Where was it sold?
FL, VA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
Other Tramadol recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP, 50 mg recalledTramadol Hydrochloride | 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 50 mg, Unit Dose Tablets recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Tramadol Hydrochloride Tablets USP 100mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |