NAPROXEN ORAL SUSPENSION recall
FDA recall D-0523-2026 · initiated Apr 20, 2026
Acella Pharmaceuticals, LLC recalled NAPROXEN ORAL SUSPENSION in Apr 2026 — an FDA Class II recall (D-0523-2026) because Chemical contamination; presence of lead and lithium above specification.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Chemical contamination; presence of lead and lithium above specification
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6,336 bottles
Details
- Product
- 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
- Recalling company
- Acella
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Apr 20, 2026
- FDA report date
- May 13, 2026
Frequently asked
- Was NAPROXEN ORAL SUSPENSION recalled?
- Acella Pharmaceuticals, LLC recalled NAPROXEN ORAL SUSPENSION in Apr 2026 — an FDA Class II recall (D-0523-2026) because Chemical contamination; presence of lead and lithium above specification. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was NAPROXEN ORAL SUSPENSION recalled?
- Per the FDA enforcement record, the reason for recall D-0523-2026 was: Chemical contamination; presence of lead and lithium above specification
- Is a recalled NAPROXEN ORAL SUSPENSION dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of NAPROXEN ORAL SUSPENSION are affected?
- Distributed: Nationwide. The recall covers these lots — Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0523-2026.