Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
LORTUSS EX Recalled by Poly Pharmaceuticals, Inc Due to Does Not Meet Monograph: Phenylephrine and pseudoephedrine are...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Poly Pharmaceuticals, Inc directly.
Affected Products
LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16.
Quantity: 102 Bottles
Why Was This Recalled?
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Poly Pharmaceuticals, Inc
Poly Pharmaceuticals, Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report