Zydus recalls
9 federal recalls on file, showing the 8 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Zydus and put it in plain English.
Recent recalls
Zydus Hydrocortisone Sodium Succinate injection recalled for impurity concernsZydus Pharmaceuticals is recalling specific lots of Hydrocortisone Sodium Succinate for Injection because the drug failed quality testing for impurities and degradation. The affected lots (LB00047A and LB00048A, expiring 03/2028) were distributed nationwide. No injuries have been reported.
ModerateFDAOct 21, 2026
- Zydus mirabegron extended-release tablets recalled for N-nitroso impurity
Zydus Pharmaceuticals is recalling one lot of Mirabegron Extended-Release 25 mg tablets due to higher-than-acceptable levels of N-Nitroso Mirabegron impurity. This impurity can potentially increase long-term health risks with continued use. No injuries have been reported.
ModerateFDAAug 12, 2026
- Zydus erythromycin tablets recalled for nitrosamine impurity above limit
Zydus Pharmaceuticals is recalling erythromycin tablets (250 mg) due to the presence of N-Nitroso-Desmethyl-Erythromycin, a nitrosamine impurity, at levels above the FDA's acceptable intake limit. The affected bottles were distributed nationwide. This impurity can potentially increase cancer risk with long-term exposure.
ModerateFDAMay 27, 20262 products
- Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
FDAMar 18, 2026
- Zydus icosapent ethyl capsules recalled for subpotency
Zydus Pharmaceuticals is recalling Icosapent Ethyl 1-gram capsules because some bottles may contain capsules that have lost potency (strength) due to leakage and oxidation. This means the medication may not work as intended. The recall affects specific lot numbers expiring in February and April 2027.
ModerateFDAJan 28, 2026
- Check your trazodone tablets for dents
Zydus Pharmaceuticals is recalling certain bottles of trazodone 100mg tablets because some tablets have dents on the surface. The defect affects lot EA00237A with an expiration date of 04/30/2027. No injuries have been reported.
FDAJan 7, 2026
- Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
FDANov 26, 2025
- clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
FDANov 12, 20253 products