The healthcare giant in April shut down a suburban Philadelphia plant that's now linked to eight recalls of Tylenol and other nonprescription drugs for children and adults.
Now the Food and Drug Administration has filed a critical report after a recent inspection found problems at another Pennsylvania plant, in Lancaster.
J&J says it's addressing FDA's concerns as quickly as possible.
The plant is operated by a joint venture called Johnson & Johnson/Merck Consumer Pharmaceuticals. The business sells products including heartburn medicines Mylanta and Pepcid.
An FDA spokeswoman says the report is still under review and cannot be released yet.