Acella Pharmaceuticals, LLC 2026-05-13 Health serious FDA
Health · FDA · Recall #FDA-D-0523-2026
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed… Recall
Issued May 13, 2026 · Acella Pharmaceuticals, LLC
In May 2026, Acella Pharmaceuticals, LLC recalled the NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Chemical contamination; presence of lead and lithium above specification
What you should do
- 1 Stop using NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Acella Pharmaceuticals, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Acella Pharmaceuticals, LLC
- Category
- Health
- Recall date
- May 13, 2026
- Units affected
- Not reported
- Sold at
- Nationwide
- Recall number
- FDA-D-0523-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Acella Pharmaceuticals, LLC has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.