chloroproMAZINE Hydrochloride Tablets recall
FDA recall D-0643-2025 · initiated Aug 25, 2025
AvKARE recalled chloroproMAZINE Hydrochloride Tablets in Aug 2025 — an FDA Class II recall (D-0643-2025) because Presence of a foreign substance.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of a foreign substance.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 1512 cartons
Details
- Product
- chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
- Recalling company
- AvKARE
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Aug 25, 2025
- FDA report date
- Sep 17, 2025
Frequently asked
- Was chloroproMAZINE Hydrochloride Tablets recalled?
- AvKARE recalled chloroproMAZINE Hydrochloride Tablets in Aug 2025 — an FDA Class II recall (D-0643-2025) because Presence of a foreign substance. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was chloroproMAZINE Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0643-2025 was: Presence of a foreign substance.
- Is a recalled chloroproMAZINE Hydrochloride 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 chloroproMAZINE Hydrochloride Tablets are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot # 46824, Exp 9/30/25; 47171, Exp 12/31/25. 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-0643-2025.