The caplets have a musty odor linked to a trace chemical, known as TBA, and may cause some mild stomach problems. The company says there's no serious health threat.
The Extra Strength caplets, in 225 count bottles, were made in February 2009 and distributed in the U.S. The lot number is ABA619 and the UPC code is 300450444271.
Consumers who purchased the recalled pills are advised to stop using the product. They can request a refund or product coupon by contacting McNeil Consumer Healthcare at 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. ET) or online at www.mcneilproductrecall.com.
Since September 2009, Johnson & Johnson has had about two dozen recalls of prescription and nonprescription medicines, replacement hips, contact lenses and diabetes test strips, including tens of millions of bottles of children's and adult Tylenol and Motrin.
The Associated Press contributed to this report.