SUN PHARMACEUTICAL INDUSTRIES INC recall records

33 reported ongoing

87 records in this archive. Latest source date Sep 14, 2026. 1 published notices do not supply a closure status.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA drug enforcement

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, M...

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIReported completed

Distribution: Nationwide in the USA

Official source for Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once D...
FDA drug enforcement

Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharma...

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIReported completed

Distribution: Nationwide in the USA

Official source for Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun ...
FDA drug enforcement

Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmac...

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIReported completed

Distribution: Nationwide in the USA

Official source for Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun P...
FDA drug enforcement

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 b...

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIReported completed

Distribution: Nationwide in the USA

Official source for Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distrib...
FDA drug enforcement

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...

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIReported completed

Distribution: Nationwide in the USA

Official source for Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distribu...
FDA drug enforcement

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,...

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIReported completed

Distribution: Nationwide in the USA

Official source for Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per...
FDA drug enforcement

Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limi...

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

Class IIReported terminated

Distribution: Distributed nationwide in the USA.

Official source for Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industr...
FDA drug enforcement

Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC...

Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.

Class IIIReported terminated

Distribution: Nationwide in the USA

Official source for Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (ND...

Reasons in these listed records

  • CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
  • Failed Impurities/Degradation Specifications
  • Failed Dissolution Specifications
  • Failed Impurities/Degradation Specifications.

These examples come from this result page and are not a ranking of every recall reason.

Checking SUN PHARMACEUTICAL INDUSTRIES INC

Is there a recall on sun pharmaceutical industries inc right now?

This archive contains 87 records, including 33 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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