--- title: "Acella Pharmaceuticals, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Acella 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/acella-pharmaceuticals-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Acella Pharmaceuticals, LLC recall records **2** reported ongoing 6 records in this archive. Latest source date Apr 20, 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 20, 2026 FDA drug enforcement ### [NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16](https://isitonrecall.com/recall/fda-drug-d-0523-2026-naproxen-oral-suspension-usp-125-mg-5ml-rx-only-16fl-oz-473-ml-bottles-distributed-by-acella-pharmac/) Chemical contamination; presence of lead and lithium above specification Class II Reported ongoing Distribution: Nationwide [Official source for NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Ace...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0523-2026%22) Sep 29, 2025 FDA drug enforcement ### [Doxycycline Hyclate Tablets, USP 100 mg\*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.](https://isitonrecall.com/recall/fda-drug-d-0014-2026-doxycycline-hyclate-tablets-usp-100-mg-500-count-bottle-rx-only-distributed-by-acella-pharmaceutical/) Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Doxycycline Hyclate Tablets, USP 100 mg\*, 500-count bottle, Rx Only, Distributed by: Acella Pharm...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0014-2026%22) Apr 24, 2024 FDA drug enforcement ### [Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06](https://isitonrecall.com/recall/fda-drug-d-0490-2024-sodium-sulfacetamide-10-sulfur-5-cleanser-rx-only-6-oz-170-3-g-bottle-manufactured-for-acela-pharmac/) Subpotent drug Class III Reported terminated Distribution: Nationwide in the US and Puerto Rico. [Official source for Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for A...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0490-2024%22) Nov 14, 2022 FDA drug enforcement ### [Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC A...](https://isitonrecall.com/recall/fda-drug-d-0069-2023-phenytoin-sodium-injection-usp-100-mg-2-ml-ndc-42192-614-02-packaged-in-10-x-2-ml-vials-per-carton-n/) Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. Class III Reported terminated Distribution: Nationwide in the USA. [Official source for Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per ca...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0069-2023%22) Nov 14, 2022 FDA drug enforcement ### [Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC ...](https://isitonrecall.com/recall/fda-drug-d-0070-2023-phenytoin-sodium-injection-usp-250-mg-5-ml-ndc-42192-614-05-packaged-in-10-x-5-ml-vials-per-carton-n/) Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. Class III Reported terminated Distribution: Nationwide in the USA. [Official source for Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per c...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0070-2023%22) Nov 14, 2022 FDA drug enforcement ### [Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC A...](https://isitonrecall.com/recall/fda-drug-d-0074-2023-sodium-sulfacetamide-10-sulfur-4-cleansing-pads-net-weight-3-7g-60-cleansing-pads-net-weight-3-7-g-e/) Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period. Class III Reported terminated Distribution: USA Nationwide [Official source for Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0074-2023%22) ## Reasons in these listed records - Chemical contamination; presence of lead and lithium above specification - Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. - Subpotent drug - Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. These examples come from this result page and are not a ranking of every recall reason. ## Checking Acella Pharmaceuticals, LLC ### Is there a recall on acella pharmaceuticals, llc right now? This archive contains 6 records, including 2 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 Acella Pharmaceuticals, LLC](https://isitonrecall.com/check/?q=Acella%20Pharmaceuticals%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)