CLASS II Drug recall · Reported 31 Jul 2019 · FDA Enforcement Report
Hydrocodone Polistirex and Chlorpheniramine Polistirex recalled
Tris Pharma is recalling Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, distributed nationwide in the US. The recall was initiated on 11 Jul 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1517-2019
- FDA event ID
- 83346
- Recalling firm
- Tris Pharma, Monmouth Junction, NJ
- Manufacturer
- Cranbury Pharmaceuticals, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jul 2019
- FDA classified
- 24 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 11 Jul 2019 | Recall initiated by company | |
| 24 Jul 2019 | Classified by FDA | +13 days |
| 31 Jul 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Which lots are affected?
Lot#: 14079, Exp 10/2021
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Tris Pharma
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | infants* Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |