CLASS II Drug recall · Reported 6 Nov 2024 · FDA Enforcement Report
Chlorpheniramine Maleate recalled by BLI International
BLI International is recalling Chlorpheniramine Maleate, distributed in Missouri. The recall was initiated on 21 Oct 2024 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-0029-2025
- FDA event ID
- 95590
- Recalling firm
- BLI International, Deer Park, NY
- Manufacturer
- Athlete's Needs, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Oct 2024
- FDA classified
- 30 Oct 2024
- Reported
- 6 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 21 Oct 2024 | Recall initiated by company | |
| 30 Oct 2024 | Classified by FDA | +9 days |
| 6 Nov 2024 | 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: Stability failure for assay at 6 months test time-point.
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
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Where it was distributed
Product was shipped to two private label customers ( OH & MO) as a final packaged product.
Questions about this recall
Why was it recalled?
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Which lots are affected?
Lot # 24A27724, Exp 01/31/2027
Where was it sold?
Product was shipped to two private label customers ( OH & MO) as a final packaged product.
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.
Other Chlorpheniramine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Chlorpheniramine/Hyoscyamine 10MG/0.25MG/ML Injectable recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Nohist-dm Antihistamine/Antitussive Nasal Decongestant recalledNohist Dm | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine recalledAdvil Allergy And Congestion Relief | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide |
| Drug | CLASS II | Gencontuss (Chlorpheniramine Maleate, 2mg recalled by Pharma-NaturalGencontuss | Pharma-Natural | Potency & Assay | Nationwide |
| Drug | CLASS II | Chlorpheniramine Maleate 10 mg/ml MDV, Rx recalled by Pharmacy Plus | Pharmacy Plus | Sterility | MS |