FDA Cites Zydus Lifesciences Limited in June 2, 2026 Warning Letter — Request for Records/CGMP/Finished Pharmaceuticals/Adulterated

FDA Warning Letter — Violations FDA cited at Zydus Lifesciences Limited

WARNING LETTER Zydus Lifesciences Limited MARCS-CMS 722576 — June 02, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Reference #: 320-26-92 Product: Drugs Recipient: Recipient Name Dr. Sharvil Patel Recipient Title Managing Director Zydus Lifesciences Limited Near Vaishnodevi Circle, S. G. Highway Ahmedabad 382481 Gujarat India Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-92 June 2, 2026 Dear Dr. Patel: Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of prescription drug products. FDA has reviewed the records you submitted in response to our November 7, 2025 request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Zydus Lifesciences Limited, FEI 3005430968, at Village Swaraj Majra, P.O. Baddi, Tehsil-Nalagarh, Solan Himachal Pradesh. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)). Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following: 1. Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and failed to test samples for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84). Your firm manufactures prescription (b)(4) drug products containing talc. (b)(4) USP is composed of more than (b)(4) % talc. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Asbestos is a potential contaminant in talc and is a known human carcinogen when inhaled. 1,2 Additionally, published scientific literature dating back to the 1960s has suggested a possible association between the use of (b)(4) containing talc in the (b)(4) area and the incidence of (b)(4) , potentially linked to asbestos contamination of the talc. 3 The (b)(4) you produce can be used on areas of the body which may be an exposure risk (e.g., inhalation or (b)(4) area). Your product is also labeled for use in (b)(4) . Your drug product, (b)(4) USP, is considered a higher-risk drug as it pertains to patient safety regarding asbestos contamination of talc due to the risk of inadvertent inhalation or potential use in the (b)(4) area. You have not demonstrated that you have appropriately tested incoming talc, a drug component, used in the manufacture of your (b)(4) drug products. For example, your internal testing procedures and specifications are written in accordance with the current United States Pharmacopeia (USP) specification for absence of asbestos, however, your records do not demonstrate you are testing to current USP requirements. For asbestos testing your data refers to identification testing by Infrared (IR) Spectroscopy. Current USP absence of asbestos procedure (b)(4) by Infrared (IR) Spectroscopy includes the evaluation of the presence of tremolite chlorite and serpentines, through scale expansions of spectra at the required wavenumbers at (b)(4) cm- 1 , and in the range of (b)(4) cm- 1 to (b)(4) cm- 1 . Your instrument reports for the identification spectroscopy was from (b)(4) cm- 1 to (b)(4) cm- 1 wavenumbers and did not include any scale expansions. Your