Prodose recalls ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg caplets over wrong label on bottle
The outer carton correctly names the product as Acetaminophen 500 mg, but the label on the bottle inside says ValuHealth Extra Strength Pain Relief PM, so the two labels do not match.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle, Distributed by:Prodose, Inc. Ronkonkoma, NY 11779, Made in India. UPC 8 50026 88900 0
- Company
- Prodose, Inc.
- Hazard
- Incorrect label placed on product: Outer carton label correctly identifies drug product in bottle as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg,but inner label on bottle says ValuHealth Extra Strength Pain Relief PM
- Units
- 100,134 40-count bottles
- Where sold
- Nationwide in the USA
- FDA classification
- Class III · Ongoing
- Classified by FDA
- October 26, 2026
- Recall started
- October 14, 2026
- FDA enforcement report
- November 4, 2026
- Identifiers
- Codes: Lot #: P260252, Exp 4/30/2029
- FDA recall number: D-0081-2027
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle, Distributed by:Prodose, Inc. Ronkonkoma, NY 11779, Made in India. UPC 8 50026 88900 0
- Reason for recall
- Incorrect label placed on product: Outer carton label correctly identifies drug product in bottle as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg,but inner label on bottle says ValuHealth Extra Strength Pain Relief PM
- Classification
- Class III (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 100,134 40-count bottles
Related recalls
Aero Healthcare recalls Acetaminophen 500mg Caffeine 65mg caplets over box label mix-up
The outer box wrongly lists Acetaminophen 500mg and Caffeine 65mg as the ingredients, while the inner pouch correctly lists Aspirin (NSAID)*500mg and Caffeine 32.5mg.