Chlorpheniramine Maleate 4 mg tablets recall
FDA recall D-0029-2025 · initiated Oct 21, 2024
BLI International, Inc. recalled Chlorpheniramine Maleate 4 mg tablets in Oct 2024 — an FDA Class II recall (D-0029-2025) because Superpotent Drug: Stability failure for assay at 6 months test time-point.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,901 cases/24 count each case
Details
- Product
- Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
- Recalling company
- BLI International, Inc.
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Product was shipped to two private label customers ( OH & MO) as a final packaged product.
- Initiated
- Oct 21, 2024
- FDA report date
- Nov 6, 2024
Frequently asked
- Was Chlorpheniramine Maleate 4 mg tablets recalled?
- BLI International, Inc. recalled Chlorpheniramine Maleate 4 mg tablets in Oct 2024 — an FDA Class II recall (D-0029-2025) because Superpotent Drug: Stability failure for assay at 6 months test time-point. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Chlorpheniramine Maleate 4 mg tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0029-2025 was: Superpotent Drug: Stability failure for assay at 6 months test time-point.
- Is a recalled Chlorpheniramine Maleate 4 mg tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Chlorpheniramine Maleate 4 mg tablets are affected?
- Distributed: Product was shipped to two private label customers ( OH & MO) as a final packaged product.. The recall covers these lots — Lot # 24A27724, Exp 01/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0029-2025.