Zydus

Zydus Pharmaceuticals is recalling erythromycin 500 mg tablets because testing found a chemical impurity (N-Nitroso-Desmethyl-Erythromycin) at levels higher than FDA's recommended safe intake limit. The impurity resulted from manufacturing process deviations at the maker in India. No injuries have been reported.

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.

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

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.

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.

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Zydus Pharmaceuticals is recalling one lot of Entecavir 0.5 mg tablets because testing found an organic impurity that exceeded acceptable limits. The affected lot (E409308, expiring 12/31/2026) was distributed nationwide. No injuries have been reported.