Recall Atlas

Acella Pharmaceuticals recalls

5 official recalls and safety alerts involving Acella Pharmaceuticals since 2022-11, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Acella Pharmaceuticals or the relevant agency.

  1. 2026-05-13
  2. US
    Drugs & medicalClass II

    Acella Pharmaceuticals, LLC recalls NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC,…

    Chemical contamination; presence of lead and lithium above specification

    FDA · DrugAcella Pharmaceuticals, LLCNationwideOfficial notice →
  3. 2025-10-15
  4. US
    Drugs & medicalClass II

    Acella Pharmaceuticals, LLC recalls Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA…

    Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

    FDA · DrugAcella Pharmaceuticals, LLCNationwide in the USAOfficial notice →
  5. 2024-05-15
  6. US
    Drugs & medicalClass III

    Acella Pharmaceuticals, LLC recalls Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC…

    Subpotent drug

    FDA · DrugAcella Pharmaceuticals, LLCNationwide in the US and Puerto Rico.Official notice →
  7. 2022-12-07
  8. US
    Drugs & medicalClass III

    Acella Pharmaceuticals, LLC recalls Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only,…

    Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.

    FDA · DrugAcella Pharmaceuticals, LLCUSA NationwideOfficial notice →
  9. 2022-11-30
  10. US
    Drugs & medicalClass III

    Acella Pharmaceuticals, LLC recalls 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,…

    Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

    FDA · DrugAcella Pharmaceuticals, LLCNationwide in the USA.Official notice →