Over 140,000 Bottles: The Atorvastatin Recall You Should Know

• Over 141,000 bottles of atorvastatin were recalled on September 19, 2025, because some pills failed to dissolve properly during testing. This may reduce how well the drug works to lower cholesterol.
• The issue is not dangerous but may make the drug less effective. The recall is voluntary and classified as Class II by the FDA.
• Do not stop taking your medication. Check your bottle’s lot number and contact your pharmacist or doctor for guidance. Store the recalled bottle separately and avoid sharing it.

On September 19, 2025, over 141,000 bottles of atorvastatin calcium tablets (generic for Lipitor^®) were recalled due to a manufacturing issue. Some tablets were found not to dissolve properly, which could reduce how well the medication works in your body.

Atorvastatin is a statin used to lower cholesterol and reduce the risk of heart attack and stroke. If the tablet doesn’t dissolve correctly, your body may not absorb enough of the medicine, making it less effective.

Why Was It Recalled?

The pills failed a dissolution test — meaning they may not break down properly in your stomach.

The recall is a Class II recall, which means the issue is:

• Not likely to cause serious harm
• May cause temporary or mild effects

It was marked as “Voluntary: Firm initiated.” That means the manufacturer acted on its own instead of waiting for an FDA order. The company decided to take the affected bottles off the market to keep patients safe.

Which Products Are Impacted?

The recall includes multiple strengths of atorvastatin calcium tablets sold in 90-count, 500-count, and 1,000-count bottles.

• Manufacturer: Alkem Laboratories Ltd. (India)
• Distributor in the U.S.: Ascend Laboratories LLC (Parsippany, New Jersey)

Here’s a summary of the affected strengths, lot numbers, and expiration dates:

What Should You Do?

Do NOT stop taking your medication

The FDA says:
“Do not stop taking atorvastatin on your own.”
Stopping suddenly can cause your cholesterol to rise quickly and increase your risk of heart attack or stroke — especially if you’ve been taking it long-term.

Check your bottle’s lot number

Look for the lot number printed on your medication bottle. Compare it with the list above or use the FDA’s recall search tool.

Call your doctor or pharmacist

They can confirm whether your medication is affected and advise you on what to do next. They may recommend switching to a different batch or brand.

Store the recalled bottle separately

Keep it in a safe place away from your other medications. Do not share it with others, even if they take the same drug.

Are There Alternatives to Atorvastatin?

Yes. There are many effective alternatives including:

• For atorvastatin 10, 20 mg: ZYPITAMAG^® (2, 4 mg) is a comparable statin with similar effects on lowering cholesterol.
  Bonus: ZYPITAMAG has less impact on blood glucose than atorvastatin. Compare ZYPITAMAG and atorvastatin
• For atorvastatin 40, 80 mg: Rosuvastatin (CRESTOR^®, 20 and 40mg) will offer comparable cholesterol lowering. Compare atorvastatin and rosuvastatin

Rosuvastatin and atorvastatin are on the Marley Drug Wholesale Price List - just $70 for a year supply.