Johnson & Johnson has initiated a voluntary recall of a limited batch of Tylenol Extra Strength caplets after quality control testing detected trace levels of a chemical intermediate not intended to be present in the finished product. The recall affects products with a specific lot number distributed to pharmacies and retailers in 12 states across the Midwest and Southeast.

The company says the contamination resulted from an equipment cleaning error at a manufacturing facility in Pennsylvania. While the detected levels are below thresholds associated with adverse health effects, J&J says it is issuing the recall out of an abundance of caution and commitment to product quality.

Consumers who purchased Tylenol Extra Strength 500mg caplets with lot number TYL-2026-0312 are advised to stop taking the product and return it to the place of purchase for a full refund. Johnson & Johnson has reported the incident to the FDA and says corrective measures have been implemented at the affected manufacturing site.