More than 112,000 bottles of Amazon-brand Extra Strength Acetaminophen are being recalled nationwide.
The FDA says consumers complained about discolored tablets in the affected lots.
The recall covers 200-, 500- and 1,000-count bottles of 500 mg acetaminophen sold through Amazon.
Consumers who keep a large bottle of generic pain reliever in the medicine cabinet should check the label and lot number.
Aurobindo Pharma USA Inc. is recalling more than 112,000 bottles of Amazon-brand Extra Strength Acetaminophen, 500 mg, after receiving consumer complaints about discolored tablets, according to a U.S. Food and Drug Administration enforcement report.
The recall was initiated Sept. 18 and involves products distributed nationwide by Amazon.com Services LLC. The FDA lists the reason for the recall as “Discoloration: consumer complaints received for discolored tablets.”
Acetaminophen is the active ingredient in Tylenol, but the recalled medicine is not Tylenol-branded medication. It is a generic acetaminophen product sold under Amazon's brand.
According to the FDA information, the recall involves approximately 112,932 bottles. The medicine was sold in three bottle sizes: 200 tablets, 500 tablets and 1,000 tablets.
Check these lot numbers
Consumers can determine whether they have recalled medicine by checking the lot number printed on the bottle.
The affected lots are:
200-count bottles
ACD125040A
500-count bottles
ACD124036A
ACD124030A
ACD124042A
ACD124048B
ACD125010A
1,000-count bottles
ACD124048A
The products carry NDC numbers 72288-692-20, 72288-692-50 and 72288-692-01, depending on bottle size.
The FDA enforcement information indicates the products were manufactured in India and distributed by Amazon.com Services LLC.
Recall has not yet been classified
As of the FDA's latest information, the recall is listed as not yet classified. That means the agency has not assigned it a Class I, II or III designation reflecting the level of potential health risk.
FDA explains that recall classifications are often made after a company has already begun removing a product from the market. A Class I recall involves a reasonable probability of serious health consequences or death, Class II generally involves temporary or medically reversible health consequences, and Class III involves products unlikely to cause adverse health consequences.
The available recall information does not identify an illness or injury associated with the affected acetaminophen. The stated reason for the recall is the consumer reports of tablet discoloration.
What consumers should do
Consumers with Amazon Extra Strength Acetaminophen should first check the bottle's lot number against the recalled lots.
FDA advises consumers dealing with a medication recall to follow instructions provided by the recalling company and to check the product's lot number rather than assuming that every package of the medicine is affected.
For prescription medicines, FDA cautions patients against simply stopping treatment without consulting a health care professional because suddenly discontinuing some medications can present a greater risk than continuing them. In this case, acetaminophen is an over-the-counter pain reliever and fever reducer.
Consumers who have one of the affected bottles can also check their Amazon account for recall information. Amazon has previously said that when products purchased through its site are recalled, it can notify affected customers and provide recall and product-safety information through their accounts.
The recall underscores an important distinction for consumers who may have seen reports referring to a “Tylenol recall.” Acetaminophen is commonly associated with the Tylenol brand, but many manufacturers sell generic versions of the drug. This recall applies to the specified Amazon-brand acetaminophen products and lots, not Tylenol products.