Zydus Pharmaceuticals (USA) Inc recalls Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India,…
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Read the official notice →- Date
- 2026-05-27
- Country
- United States
- Brand
- Zydus Pharmaceuticals
- Product
- Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…
- Classification
- Class II
- Units
- Nationwide within the U.S
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Zydus Pharmaceuticals recalls
- 2026-08-12
USZydus Pharmaceuticals (USA) Inc recalls Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda,…
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- 2026-03-18
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Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India;…
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
- 2026-01-28
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Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed…
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
- 2026-01-07
- US
Zydus Pharmaceuticals (USA) Inc recalls traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India,…
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
- 2025-11-26
- US
Zydus Pharmaceuticals (USA) Inc recalls Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd.,…
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
- 2025-11-12
- US
Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC…
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Other drugs & medical recalls in the United States
- 2026-05-27
- US
Safecor Health, LLC recalls Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral…
Presence of a Foreign Substance; black particles observed in liquid
- US
- US
- US
ANI Pharmaceuticals, Inc. recalls Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette,…
Defective Container; packets were found to be either empty or partially full.
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Haleon US Holdings LLC recalls Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
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Lupin Pharmaceuticals Inc. recalls Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured…
Presence of particulate matter: a white thread-like structure in the cartridge