Tower Laboratories Ltd.

Warning LetterOpen

Mr. Norman Needleman Chief Executive Officer Tower Laboratories Ltd. 8060 Whitbeck Road Montague , MI 49437-1546 United StatesFEI 1823985Issued Dec 23, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1823985.

Violations2

Issue DateDec 23, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Tower Laboratories Ltd.
Location: Mr. Norman Needleman Chief Executive Officer Tower Laboratories Ltd. 8060 Whitbeck Road Montague , MI 49437-1546 United States
FEI Number: 1823985
Country: United States
Issue Date: December 23, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Tower Laboratories Ltd. manufactured over-the-counter drug products in violation of Current Good Manufacturing Practice (CGMP) regulations, rendering their drug products adulterated. FDA investigators found that the company failed to thoroughly investigate out-of-specification (OOS) laboratory results from October 2024 to June 2025, including failed assay testing on tablet lots at the 9-month stability timepoint, and did not implement adequate corrective and preventive actions (CAPA) or notify customers of the failing results. The inspection of the Montague, Michigan facility from July 8-11, 2025 identified deficiencies in batch investigation procedures under 21 CFR 211.192, with laboratory investigations lacking sufficient detail and root cause analysis.

Tower Laboratories Ltd. FDA Warning Letter, December 23, 2025