SUN PHARMACEUTICAL INDUSTRIES INC recalls Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries,
Sun Pharmaceutical recalls 60mg Lurasidone Hydrochloride tablets due to microbial contamination in manufacturing equipment. This could pose health risks if the tablets are taken. Consumers should check NDC 47335-639-83 and lot number DNE0620A.
Recall notice
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Contact the company & request your remedy
What happened, in plain English
Sun Pharmaceutical is recalling 60mg Lurasidone Hydrochloride tablets (Rx only) because microbial contamination was found in the manufacturing equipment. This could lead to health risks if the tablets are taken as prescribed. Read more at govinfonow.com/recall/32861-sun-pharmaceutical-lurasidone-tablets-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32861-sun-pharmaceutical-lurasidone-tablets-recall-microbial-contamination-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0266-2024
Cite this page
“Sun Pharmaceutical Lurasidone Tablets Recall: Microbial Contamination Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32861-sun-pharmaceutical-lurasidone-tablets-recall-microbial-contamination-risk. Based on FDA recall #D-0266-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0266-2024%22&limit=1).
Why it’s dangerous
Microbial contamination was detected in stagnant water within the manufacturing equipment's duct. This could lead to harmful bacteria entering the tablets during production, potentially causing health issues if consumed.
Who’s affected
Prescription patients who have the recalled Lurasidone tablets (NDC 47335-639-83, lot DNE0620A) are affected. Patients taking this medication for mental health conditions are most at risk.
How to tell if you have this one
Check for the NDC code 47335-639-83 and lot number DNE0620A on the tablet packaging. The product was distributed by Sun Pharmaceutical Industries, Inc. in the United States.
- Brand
Sun Pharmaceutical- Category
Drug
All 11 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Completed- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0263-2024 | Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.; Lot #: DNE0702A, Exp. 06/30/2026 | 1,728 bottles | 47335-379-83, 47335-380-83, 47335-600-83 |
| D-0264-2024 | Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83.; Lot #s: DNE0866B Exp. 06/30/2025, DNE1045A, DNE1046B Exp. 08/31/2025 | 55,272 bottles | 47335-721-83, 47335-721-81, 47335-721-13, 47335-722-83, 47335-722-88, 47335-722-18 |
| D-0265-2024 | Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.; Lot #s: DNE0867A Exp. 06/30/2025, DNE0894B Exp. 07/31/2025 | 19,992 bottles | 47335-721-83, 47335-721-81, 47335-721-13, 47335-722-83, 47335-722-88, 47335-722-18 |
| D-0266-2024 | Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-639-83.; Lot #: DNE0620A Exp. 05/31/2025 | 11,400 bottles | 47335-578-83, 47335-578-81, 47335-578-13, 47335-684-83, 47335-684-81, 47335-684-13, 47335-639-83, 47335-639-81, 47335-639-13, 47335-685-83, 47335-685-81, 47335-685-13, 47335-579-83, 47335-579-81, 47335-579-13 |
| D-0267-2024 | Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.; Lot #s: DNE0621A Exp. 11/30/2024, DNE0815A Exp. 12/31/2024 | 9,408 bottles | 47335-578-83, 47335-578-81, 47335-578-13, 47335-684-83, 47335-684-81, 47335-684-13, 47335-639-83, 47335-639-81, 47335-639-13, 47335-685-83, 47335-685-81, 47335-685-13, 47335-579-83, 47335-579-81, 47335-579-13 |
| D-0268-2024 | Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.; Lot #s: DNE0875A Exp. 01/31/2025; DNE0876A, DNE0877A, DNE1080A, DNE1081A Exp. 02/28/2025; DNE1147A, DNE1148A Exp. 03/31/2025. | 10,690 bottles | 63304-175-13 |
| D-0269-2024 | Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-613-81.; Lot #: DNE0788A Exp. 07/31/2025 | 6552 bottles | 47335-539-83, 47335-539-81, 47335-539-88, 47335-539-08, 47335-539-18, 47335-614-83, 47335-614-81, 47335-614-88, 47335-614-18, 47335-613-83, 47335-613-81, 47335-613-88, 47335-613-08, 47335-613-18 |
| D-0270-2024 | Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81.; Lot #s: DNE0771A Exp. 06/30/2025; DNE0857A, DNE0959A Exp. 07/31/2025. | 15,768 bottles | 47335-539-83, 47335-539-81, 47335-539-88, 47335-539-08, 47335-539-18, 47335-614-83, 47335-614-81, 47335-614-88, 47335-614-18, 47335-613-83, 47335-613-81, 47335-613-88, 47335-613-08, 47335-613-18 |
| D-0271-2024 | Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88.; Lot #: DNE0892A Exp. 07/31/2026 | 1220 bottles | 47335-307-88, 47335-307-13, 47335-308-88, 47335-308-13 |
| D-0272-2024 | Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88.; Lot #: DNE0893A Expires 07/31/2026 | 14,568 bottles | 47335-307-88, 47335-307-13, 47335-308-88, 47335-308-13 |
| D-0273-2024 | Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.; Lot #s: a) DNE0792A Exp. 06/31/2025; DNE1027A Exp. 08/31/2025. b) DNE0793A Exp. 06/31/2025. c) DNE0789A, DNE0790A, DNE0791A Exp. 06/2025, DNE1026A Exp. 08/31/025. | 54,504 bottles | 51660-998-30, 51660-998-55, 51316-800-90, 51316-800-70, 51316-800-45, 51316-800-30, 51316-800-15, 51316-800-08 |
What to do — step by step
Check Product Details
Look for the NDC code 47335-639-83 and lot number DNE0620A on the tablet packaging.
Questions people ask
Is this product safe to take?
The recall does not specify if the product is safe to take. The hazard involves microbial contamination in manufacturing equipment, which could pose health risks if the tablets are consumed.
How can I check if I have the recalled product?
Check the NDC code 47335-639-83 and lot number DNE0620A on the tablet packaging. The product was distributed by Sun Pharmaceutical Industries, Inc. in the United States.
What should I do if I have the recalled product?
The recall record does not specify a remedy. Consumers should contact Sun Pharmaceutical Industries, Inc. for further instructions.
Contact Sun Pharmaceutical
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0266-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0266-2024 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0266-2024 (January 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0266-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.