Amazon acetaminophen recall: 112,932 bottles pulled over discolored tablets
Web StoryWatch this story in 15 seconds →Key takeaways
- More than 112,000 bottles of Amazon-brand Extra Strength Acetaminophen 500 mg are recalled.
- The recall covers 7 lots in 200-count, 500-count, and 1,000-count bottles.
- Check your bottle's lot number. Stop using it if it matches the list.
Amazon-brand pain relief tablets are under recall. More than 112,000 bottles are affected. The tablets may look discolored.
Check your bottle now.
The recall covers Amazon Basic Care Extra Strength Acetaminophen 500 mg. The tablets come in caplets. The recall started on September 18, 2026. The maker is Aurobindo Pharma USA Inc.
The seller is Amazon. com Services LLC. The tablets were made in India.
What happened
Shoppers reported tablets that looked off color. The FDA lists the reason in one line. It says: "Discoloration: consumer complaints received for discolored tablets.
" The tablets should look white to off-white. The FDA posted the recall in its enforcement report on October 2, 2026.
The recall covers 112,932 bottles in total. It covers three bottle sizes. The 500-count bottles account for 90,456 bottles.
The 200-count bottles account for 14,640 bottles. The 1,000-count bottles account for 7,836 bottles.
The FDA has not yet assigned a risk class. That means the agency has not said how serious the problem is. The recall notice does not list any illness or injury tied to the tablets.
A class will come in a later report.
This is not a Tylenol recall. Acetaminophen is the active ingredient in Tylenol. But this recall covers Amazon-brand tablets only.
Other brands are not part of it.
Amazon told USA TODAY about the recall. It was done in coordination with the maker, Aurohealth, and the FDA. Aurobindo Pharma USA Inc.
did not at once respond to USA TODAY's request for comment.
This is not the first such recall. In May 2025, the firm recalled 4,608 bottles of 325 mg tablets. They were sold through Amazon.
That recall also cited tablet discoloration. The FDA placed that earlier recall in Class II. Class II is the middle risk group.
It covers products that may cause short-term or reversible harm.
Which bottles are recalled
Check the lot number on your bottle label. Only the lots below are recalled. Other lots are not part of the recall.
The lot number and expiry date sit on the bottle label.
200-count bottles (NDC 72288-692-20):
- Lot ACD125040A, expiry September 30, 2027
500-count bottles (NDC 72288-692-50):
- Lot ACD124036A, expiry September 30, 2027
- Lot ACD124030A, expiry September 30, 2027
- Lot ACD124042A, expiry October 31, 2027
- Lot ACD124048B, expiry November 30, 2027
- Lot ACD125010A, expiry February 29, 2028
1,000-count bottles (NDC 72288-692-01):
- Lot ACD124048A, expiry November 30, 2027
Why it matters
Acetaminophen is one of the most common medicines in US homes. People use it for pain and fever. Bulk bottles can sit on a shelf for months.
One bottle may serve a whole household.
A color change is a warning sign you can see. It does not by itself prove the medicine is harmful. But it shows the product is not as it should be.
Officials have not said what caused the color change. No test results have been released. Any cause you read online is unconfirmed.
Acetaminophen can slowly break down when it meets moisture. One breakdown product must stay within strict limits. Makers test for it.
That is part of US drug quality rules. But no one has linked that process to these lots. Do not guess at the cause.
Some medicines can cause side effects you do not expect. A recall is a sign to pause and check. It is not a sign to panic.
The right move is simple. Check the label. Then act on what you find.
Some people use acetaminophen for night leg cramps. If your bottle is recalled, ask a pharmacist about a replacement. Do not just skip relief you need.
A pharmacist can point you to a safe swap.
What to do with your bottle
First, check the NDC, lot number, and expiry date. Match them against the list above. If your bottle matches, stop using it.
Keep the bottle and your order details. They help with a return or refund.
Second, contact Amazon customer service about a return or refund. Amazon has said in the past that it can notify buyers of recalled products. Check your Amazon account for recall information too.
Third, ask a pharmacist about a replacement. Generic acetaminophen from other makers is widely sold. If you use acetaminophen for an ongoing condition, do not leave a gap in relief.
A pharmacist can help you pick a safe option.
If you took tablets from an affected bottle and feel fine, current facts give no reason for alarm. If you notice odd symptoms after taking the medicine, contact a pharmacist or clinician. Bad symptoms need urgent care.
These include trouble breathing, swelling of the face or throat, or yellowing of the skin or eyes.
You can also report a problem with any medicine through the FDA's MedWatch program. Reports help regulators judge if a problem is rare or wide.
This article is for information only and is not medical advice.
What happens next
The FDA will assign a risk class in a later enforcement report. That class will say how the agency views the risk. The earlier 2025 recall landed in Class II.
That is a reference point, not a forecast for this case.
Watch for updates from the FDA and Amazon. If you own one of the listed bottles, check it today. A two-minute label check is all it takes.
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