CLASS III Drug recall · Reported 3 Oct 2018 · FDA Enforcement Report
Fenofibrate Tablets, USP 145 mg recalled by Hetero Labs, Ltd. - Unit III
Hetero Labs, Ltd. - Unit III is recalling Fenofibrate Tablets, USP 145 mg, distributed in Indiana, Louisiana. The recall was initiated on 12 Sep 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-1211-2018
- FDA event ID
- 81017
- Recalling firm
- Hetero Labs, Ltd. - Unit III, Hyderabad
- Brand
- Fenofibrate
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Sep 2018
- FDA classified
- 25 Sep 2018
- Reported
- 3 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cholesterol Medication
Timeline
| 12 Sep 2018 | Recall initiated by company | |
| 25 Sep 2018 | Classified by FDA | +13 days |
| 3 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Product as listed by the FDA
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
Where it was distributed
Indiana and Louisiana
Questions about this recall
Is Fenofibrate Tablets, USP 145 mg recalled?
Yes. Hetero Labs, Ltd. - Unit III recalled Fenofibrate Tablets, USP 145 mg on 12 Sep 2018. The recall is Class III and its status is Terminated. Recall number D-1211-2018.
Why was it recalled?
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Which lots are affected?
Lot #: E181370, Exp. 5/2020
Where was it sold?
Indiana and Louisiana
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 21 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 Hetero Labs, Ltd. - Unit III
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Indomethacin Capsules, USP, 50 mg recalledIndomethacin | Hetero Labs, Ltd. - Unit III | Other | Nationwide |
| Drug | CLASS II | Aripiprazole Tablets, USP, 10 mg recalledAripiprazole | Hetero Labs, Ltd. - Unit III | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS III | Simvastatin Tablets, USP, 40 mg recalled by Hetero Labs, Ltd. - Unit IIISimvastatin | Hetero Labs, Ltd. - Unit III | Other | Nationwide |
| Drug | CLASS II | Levetiracetam Oral Solution, USP, 100 mg/mL recalledLevetiracetam | Hetero Labs, Ltd. - Unit III | Packaging Defects | NJ |
Other Fenofibrate recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fenofibrate Capsules, USP 200 mg recalled by Ajanta Pharma USAFenofibrate | Ajanta Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Fenofibrate Capsules 67 mg recalled by Glenmark PharmaceuticalsFenofibrate | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Fenofibrate Capsules, Ups 67mg recalled by Cardinal HealthFenofibrate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Fenofibrate Capsules (Micronized) 200 mg recalled by Impax Laboratories | Impax Laboratories | Other | Nationwide |
| Drug | CLASS III | Fenofibrate Capsules (Micronized) recalled | Amerisource Health Services | Packaging Defects | Nationwide |