Acella Pharmaceuticals, LLC Naproxen Oral Suspension, USP, 125 mg/5mL recall: Chemical contamination; presence of lead and lithium above specification
Chemical contamination; presence of lead and lithium above specification
The hazard: Drug safety concern
A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.
What the notice says: Chemical contamination; presence of lead and lithium above specification
Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.
Recall details
- Recall number
- D-0523-2026
- Published
- May 13, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Acella Pharmaceuticals, LLC
- Product type
- Prescription & OTC drugs
- Units affected
- 6,336 bottles
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Products covered by this recall
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
Check your product
The notice names 11 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 23F02
Best-by / use-by date
Printed beside the lot code, not on the price sticker.
- 05
- 2026
- 01
- 2028. — 6
- 336 bottles
NDC number
On the carton and again on the bottle or blister label.
- 42192-619-16
Package size
Match the net weight or the piece count on the front of the pack.
- 125 mg
- 5 mL
- 16 fl oz
- 473 mL
Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Drug safety
Acella Pharmaceuticals, LLC — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.
- Check the lot number on your pack against the codes listed above.
- Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
- Ask the dispensing pharmacy for a replacement from an unaffected lot.
- Keep the carton; the lot number is often printed only on the outer pack.
Getting a replacement supply
Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.
- Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
- Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
- Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
- If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.
Company contact: Acella Pharmaceuticals, LLC — 1880 Mcfarland Pkwy Ste 110, Alpharetta, GA, 30005-1795
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Acella Pharmaceuticals, LLC prescription & otc drugs recalled?
Chemical contamination; presence of lead and lithium above specification Chemical contamination; presence of lead and lithium above specification
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: lot code 23F02; best-by date 05 or 2026. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Check the lot number on your pack against the codes listed above.
Can I get my money back?
Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
Where was the recalled product sold?
It was distributed nationwide.
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