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

Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unithe...

Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.

Class IIIReported terminated

Distribution: Nationwide in the USA.

Official source for Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25...
FDA drug enforcement

Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Indust...

Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup

Class IIReported terminated

Distribution: Nationwide with the United States

Official source for Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm In...
FDA drug enforcement

Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC #...

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

Class IIReported terminated

Distribution: Distributed to one distributor who may have further distribute the product nationwide.

Official source for Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis...
FDA drug enforcement

Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC ...

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

Class IIReported terminated

Distribution: Distributed to one distributor who may have further distribute the product nationwide.

Official source for Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphi...
FDA drug enforcement

Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Lt...

Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.

Class IIReported terminated

Distribution: Nationwide in the USA

Official source for Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industr...

Reasons in these listed records

  • Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
  • Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
  • Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
  • Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.

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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