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Rising Pharma Holding, Inc. recall records

13 reported ongoing

13 records in this archive. Latest source date Jul 13, 2026.

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

Jul 13, 2026FDA drug enforcement

Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Labor...

Presence of Precipitate: medication was crystallizing and particles floating in the bottle

Class IIReported ongoing

Distribution: Nationwide U.S.A.

Official source

Mar 3, 2026FDA drug enforcement

Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan...

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

Class IIReported ongoing

Distribution: Nationwide within the U.S

Official source

Oct 7, 2025FDA drug enforcement

Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured b...

Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 ...

Class IIReported ongoing

Distribution: Distributed Nationwide in the USA

Official source

Mar 5, 2025FDA drug enforcement

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIReported ongoing

Distribution: Nationwide in the USA.

Official source

Dec 30, 2024FDA drug enforcement

Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc.,...

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIReported ongoing

Distribution: Nationwide

Official source

Dec 30, 2024FDA drug enforcement

Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIReported ongoing

Distribution: Nationwide

Official source

Dec 30, 2024FDA drug enforcement

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIReported ongoing

Distribution: Nationwide

Official source

Nov 19, 2024FDA drug enforcement

Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Class IIReported ongoing

Distribution: Nationwide.

Official source

Nov 19, 2024FDA drug enforcement

Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed...

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Class IIReported ongoing

Distribution: Nationwide.

Official source

Nov 19, 2024FDA drug enforcement

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceutica...

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Class IIReported ongoing

Distribution: Nationwide.

Official source

Jun 24, 2024FDA drug enforcement

Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 0...

Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.

Class IIIReported ongoing

Distribution: Nationwide in the USA

Official source

May 16, 2024FDA drug enforcement

Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-...

Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.

Class IIIReported ongoing

Distribution: Nationwide in the USA

Official source

Dec 29, 2023FDA drug enforcement

buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured...

Presence of Foreign Tablets/Capsules

Class IIReported ongoing

Distribution: Nationwide within the United States

Official source

Reasons in these listed records

Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

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

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Is there a recall on rising pharma holding, inc. right now?

This archive contains 13 records, including 13 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.

Records and reported status

Reasons in these listed records

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