Zydus Pharmaceuticals (USA) recalls
FDA enforcement reports naming Zydus Pharmaceuticals (USA) Inc as the recalling firm.
- Recall reports
- 54
- Class I (serious)
- 2
- Most recent report
- Aug 12, 2026
- Aug 12, 2026Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by:…Drug · Zydus Pharmaceuticals (USA) IncCGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.Class II
- May 27, 2026Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zyd…Drug · Zydus Pharmaceuticals (USA) IncCGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limitClass II
- May 27, 2026Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zyd…Drug · Zydus Pharmaceuticals (USA) IncCGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limitClass II
- Mar 18, 2026Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: So…Drug · Zydus Pharmaceuticals (USA) IncFailed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.Class II
- Jan 28, 2026Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel…Drug · Zydus Pharmaceuticals (USA) IncSubpotent Drug: Due to oxidation caused by leakage of the contents of the capsulesClass II
- Jan 7, 2026traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Z…Drug · Zydus Pharmaceuticals (USA) IncFailed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.Class III
- Nov 26, 2025Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx OnlyDrug · Zydus Pharmaceuticals (USA) IncFailed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.Class II
- Nov 12, 2025clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC…Drug · Zydus Pharmaceuticals (USA) InccGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.Class II
- Nov 12, 2025clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC…Drug · Zydus Pharmaceuticals (USA) InccGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.Class II
- Nov 12, 2025clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC…Drug · Zydus Pharmaceuticals (USA) InccGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.Class II
- Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifescie…
- Entecavir Tablets, USP, 0
- Entecavir Tablets, USP, 0
- Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd
- Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactu…
- Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multipl…
- Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactu…
- Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactur…
- Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactur…
- Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactu…
- Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactu…
- Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactur…
- Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactur…
- Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactu…
- Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactur…
- Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Dopp…
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose…
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose…
- Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg
- chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufact…
- Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial
- Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packet…
- Venlafaxine Hydrochloride Extended-Release Capsules, USP 37
- Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactu…
- Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2
- Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by:…
- Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for…
- Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2
- Estradiol Transdermal System, USP (Twice-Weekly) 0
- Estradiol Transdermal System, USP (Twice-Weekly) 0
- Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Man…
- Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Man…
- Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manu…
- Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-0…
- Colchicine Tablets, USP 0
- Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes,…
- Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila He…
- Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous…
- Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous…
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10…
- Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 un…
- Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10…
- Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10…
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