The FDA announced today that there is a nationwide acetamenophen recall which affects 11 million bottles of the drug. The recall covers store-brand acetamenophen, not brand-name Tylenol products, is voluntary, and is being conducted by Michigan-based Perrigo Company due to metal fragments being found in a small number of the pills.
FDA is currently investigating the cause of the metal particles found in the acetaminophen 500 mg. caplets. Perrigo originally informed FDA of this problem after discovering through their own regulatory quality control procedures that their tableting equipment was wearing down prematurely. The company is also investigating the cause of the problem. The ongoing investigations have revealed the presence of the metal fragments in caplets of acetaminophen, 500 mg. Perrigo reported to the FDA that 70 million caplets were passed through a metal detector; resulting in the discovery of approximately 200 caplets containing metal fragments ranging in size from “microdots” to portions of wire 8 mm in length.