CLASS III Drug recall · Reported 24 Jan 2018 · FDA Enforcement Report
Simvastatin Tablets, USP, 40 mg recalled by Hetero Labs, Ltd. - Unit III
Hetero Labs Ltd. - Unit III is recalling Simvastatin Tablets, USP, 40 mg, distributed nationwide in the US. The recall was initiated on 22 Dec 2017 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-0223-2018
- FDA event ID
- 78821
- Recalling firm
- Hetero Labs Ltd. - Unit III, Hyderabad, N/A
- Brand
- Simvastatin
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Dec 2017
- FDA classified
- 16 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cholesterol Medication
Timeline
| 22 Dec 2017 | Recall initiated by company | |
| 16 Jan 2018 | Classified by FDA | +25 days |
| 24 Jan 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 substance: metallic razor blade was found in one bottle.
Product as listed by the FDA
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
Where it was distributed
U.S.A. nationwide
Questions about this recall
Why was it recalled?
Presence of foreign substance: metallic razor blade was found in one bottle.
Which lots are affected?
Lot #: E171280, Exp 06/19
Where was it sold?
U.S.A. nationwide
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.
More recalls from Hetero Labs Ltd. - Unit III
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fenofibrate Tablets, USP 145 mg recalled by Hetero Labs, Ltd. - Unit IIIFenofibrate | Hetero Labs Ltd. - Unit III | Other | IN, LA |
| 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 II | Levetiracetam Oral Solution, USP, 100 mg/mL recalledLevetiracetam | Hetero Labs Ltd. - Unit III | Packaging Defects | NJ |
Other Simvastatin recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP 20 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin Tablets, USP, 40 mg, Packaged as: a) bottle recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin Tablets, USP, 20 mg, Packaged as: a) bottle recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |