--- title: "Amneal Pharmaceuticals, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Amneal Pharmaceuticals, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/amneal-pharmaceuticals-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Amneal Pharmaceuticals, LLC recall records **10** reported ongoing 14 records in this archive. Latest source date Jun 3, 2026. 2 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 3, 2026 FDA drug enforcement ### [Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed b...](https://isitonrecall.com/recall/fda-drug-d-0585-2026-primidone-tablets-usp-50-mg-100-tablets-per-bottle-rx-only-manufactured-by-amneal-pharmaceuticals-pv/) Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. Class III Reported ongoing Distribution: Nationwide within the USA. [Official source for Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceu...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0585-2026%22) Mar 24, 2026 FDA company announcement ### [Amneal: Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag](https://isitonrecall.com/recall/fdapress-ca3b5a73b6716a8e-amneal-magnesium-sulfate-in-water-for-injection-usp-4g-100ml-iv-bag/) A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL. Not supplied Published notice; closure not supplied Distribution: Not supplied [Official source for Amneal: Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-magnesium-sulfate-water-injection-usp) Mar 19, 2026 FDA drug enforcement ### [traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharma...](https://isitonrecall.com/recall/fda-drug-d-0408-2026-tramadol-hydrochloride-tablets-usp-50-mg-500-count-bottles-rx-only-manufactured-by-amneal-pharmaceut/) Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH). Class II Reported ongoing Distribution: Nationwide within the USA [Official source for traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal P...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0408-2026%22) Mar 18, 2026 FDA drug enforcement ### [Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. L...](https://isitonrecall.com/recall/fda-drug-d-0478-2026-magnesium-sulfate-in-water-for-injection-4g-100-ml-40mg-ml-iv-bag-further-packaged-in-cartons-of-12/) Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead. Class I Reported ongoing Distribution: U.S.A. Nationwide [Official source for Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0478-2026%22) Aug 18, 2025 FDA drug enforcement ### [Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; M...](https://isitonrecall.com/recall/fda-drug-d-0615-2025-sulfamethoxazole-and-trimethoprim-tablets-usp-800mg-160mg-double-strength-rx-only-packaged-as-a-100/) Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0615-2025%22) Aug 18, 2025 FDA drug enforcement ### [chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA,...](https://isitonrecall.com/recall/fda-drug-d-0616-2025-chlorpromazine-hydrochloride-tablets-usp-25-mg-100-count-bottles-rx-only-manufactured-by-amneal-phar/) Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Am...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0616-2025%22) Aug 18, 2025 FDA drug enforcement ### [chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; ...](https://isitonrecall.com/recall/fda-drug-d-0617-2025-chlorpromazine-hydrochloride-tablets-usp-50-mg-100-count-bottle-rx-only-manufactured-by-amneal-pharm/) Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amn...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0617-2025%22) Aug 18, 2025 FDA drug enforcement ### [chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA;...](https://isitonrecall.com/recall/fda-drug-d-0618-2025-chlorpromazine-hydrochloride-tablets-usp-100-mg-100-count-bottle-rx-only-manufactured-by-amneal-phar/) Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Am...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0618-2025%22) Aug 18, 2025 FDA drug enforcement ### [chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA;...](https://isitonrecall.com/recall/fda-drug-d-0619-2025-chlorpromazine-hydrochloride-tablets-usp-200-mg-100-count-bottles-rx-only-manufactured-by-amneal-pha/) Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Am...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0619-2025%22) Jun 2, 2025 FDA drug enforcement ### [Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured b...](https://isitonrecall.com/recall/fda-drug-d-0488-2025-sulfamethoxazole-and-trimethoprim-tablets-usp-400-mg-80-mg-rx-only-a-100-tablets-per-bottle-ndc-6516/) Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. Class I Reported ongoing Distribution: Nationwide in the USA [Official source for Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0488-2025%22) Apr 18, 2025 FDA company announcement ### [Amneal Pharmaceuticals LLC.: Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag](https://isitonrecall.com/recall/fdapress-7d56cbc0cded1044-amneal-pharmaceuticals-llc-ropivacaine-hydrochloride-injection-usp-500mg-100ml-iv-bag/) Product may contain an inert fiber identified as polypropylene fibers from the IV bag Not supplied Published notice; closure not supplied Distribution: The recalled product was distributed nationwide to wholesalers/distributors between the dates of 04/23/2024 to 11/8/2024 only. [Official source for Amneal Pharmaceuticals LLC.: Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-ropivacaine-hydrochloride-injection-usp) Apr 17, 2025 FDA drug enforcement ### [Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceu...](https://isitonrecall.com/recall/fda-drug-d-0402-2025-ropivacaine-hydrochloride-injection-usp-0-5-500-mg-per-100-ml-5mg-ml-manufactured-by-amneal-pharmace/) Presence of Particulate Matter Class I Reported ongoing Distribution: Nationwide in the US [Official source for Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amne...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0402-2025%22) Aug 1, 2024 FDA drug enforcement ### [Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1](https://isitonrecall.com/recall/fda-drug-d-0629-2024-methotrexate-tablets-usp-2-5mg-100-count-bottle-rx-only-distributed-by-amneal-pharmaceuticals-llc-br/) Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle. Class III Reported completed Distribution: Nationwide in the USA [Official source for Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceutica...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0629-2024%22) Mar 27, 2024 FDA company announcement ### [Amneal: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL](https://isitonrecall.com/recall/fdapress-2ac17743686da5b4-amneal-vancomycin-hydrochloride-for-oral-solution-usp-250-mg-5ml/) Super potent due to bottles being overfilled Not supplied Reported terminated Distribution: Not supplied [Official source for Amneal: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution) ## Reasons in these listed records - Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. - A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL. - Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH). - Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead. These examples come from this result page and are not a ranking of every recall reason. ## Checking Amneal Pharmaceuticals, LLC ### Is there a recall on amneal pharmaceuticals, llc right now? This archive contains 14 records, including 10 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](https://isitonrecall.com/guides/read-lot-codes/) 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](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/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. ## Keep checking [Search Amneal Pharmaceuticals, LLC](https://isitonrecall.com/check/?q=Amneal%20Pharmaceuticals%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)