Simvastatin Tablets Recalled Due to Presence of Metallic Razor Blade
Hetero Labs is recalling specific lots of Simvastatin 40 mg tablets because a metallic razor blade was found in one bottle.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sharp metallic object) where injury has not yet been reported, fitting the High severity criteria for theoretical or unreported harm.
Plain-English summary
Hetero Labs, Ltd. - Unit III is recalling Simvastatin Tablets, USP, 40 mg, 1000-count bottles. The recall is due to the presence of a foreign substance, specifically a metallic razor blade, which was found in one bottle.
The affected product is identified by Lot # E171280 with an expiration date of 06/19. The product is manufactured for Camber Pharmaceuticals, Inc. and distributed nationwide in the U.S.A.
Consumers with this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the product or obtain a replacement.
The recalled product
- Product
- SIMVASTATIN (SIMVASTATIN)
- Brand
- SIMVASTATIN
- Manufacturer
- Hetero Labs, Ltd. - Unit III
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: E171280
- Exp 06/19
UPCs (2)
- 0331722511308
- 0331722510301
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · SIMVASTATIN
- ModerateSimvastatin Tablets Recalled Due to Manufacturing Practice Deviations
FDA (Drugs) · 2023-03-08
- HighSimvastatin 40 mg tablets recalled for manufacturing practice deviations
FDA (Drugs) · 2023-03-08
- ModerateSimvastatin tablets recalled due to manufacturing process deviations
FDA (Drugs) · 2023-03-08
- HighPrescription Drug Simvastatin Recalled for Manufacturing Deviations
FDA (Drugs) · 2023-03-08
- HighAccord Healthcare Simvastatin 80 mg Tablets Recalled for Manufacturing Practice Violations
FDA (Drugs) · 2023-03-08
Same manufacturer · Hetero Labs, Ltd. - Unit III
See all →- ModerateFenofibrate Tablets Recalled Due to Foreign Valacyclovir Tablet Presence
FDA (Drugs) · 2018-10-03
- ModerateHetero Labs Recalls Indomethacin Capsules Due to Deformed or Clumped Units
FDA (Drugs) · 2018-08-08
- ModerateHetero Labs Recalls Aripiprazole Tablets Due to CGMP Deviations
FDA (Drugs) · 2018-02-14
- HighLevetiracetam Oral Solution Recalled Due to Foreign Screw Presence
FDA (Drugs) · 2017-12-06
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- HighLevetiracetam Oral Solution Recalled Due to Foreign Screw Presence
FDA (Drugs) · 2017-12-06
- ModerateAurobindo Recalls Simvastatin Tablets Due to Manufacturing Water Leakage
FDA (Drugs) · 2020-04-22
- LowMicro Labs Recalls Simvastatin Tablets Due to Impurity Failure
FDA (Drugs) · 2015-03-18
- ModerateApotex Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2019-11-06
- LowHetero USA Recalls Acyclovir Tablets Due to Human Hair Presence
FDA (Drugs) · 2017-06-14
- ModerateFenofibrate Tablets Recalled Due to Foreign Valacyclovir Tablet Presence
FDA (Drugs) · 2018-10-03