Naproxen Oral Suspension Recalled for Lead and Lithium Contamination
Acella Pharmaceuticals is recalling Naproxen oral suspension due to the presence of lead and lithium above specification levels. The recall affects 6,336 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as Class II. Chemical contamination with toxic metals (lead and lithium) in an oral suspension meets the criteria for Severe, as it represents a significant health risk from a known contaminant in a systemic drug product.
Plain-English summary
Acella Pharmaceuticals, LLC is recalling Naproxen oral suspension, USP, 125 mg/5 mL (Rx only), in 16 fl oz bottles due to chemical contamination. The product contains lead and lithium at levels above specification.
The affected product is Naproxen (NDC 42192-619-16), manufactured in Canada and distributed by Acella Pharmaceuticals in Alpharetta, Georgia. Two lots are involved: Lot 23F02 (expiring 05/2026) and Lot 25A37 (expiring 01/2028). Approximately 6,336 bottles were distributed nationwide.
Patients using this product should contact their healthcare provider or pharmacist. Do not stop taking naproxen without consulting a healthcare professional, as it is a prescription medication used to treat pain and inflammation. Return any remaining product to the pharmacy.
The recalled product
- Product
- NAPROXEN (NAPROXEN)
- Brand
- NAPROXEN
- Manufacturer
- Acella Pharmaceuticals, LLC
- Affected units
- 6,336
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: 23F02
- Expires: 05/2026
- 25A37
- Expires: 01/2028.
UPCs (1)
- 0342192619166
Distribution
Distributed nationwide across the United States.
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