chlorproMAZINE Hydrochloride Tablets recall
FDA recall D-0619-2025 · initiated Aug 18, 2025
Amneal Pharmaceuticals, LLC recalled chlorproMAZINE Hydrochloride Tablets in Aug 2025 — an FDA Class II recall (D-0619-2025) because Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
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: 3,363 100-count bottles
Details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
- Recalling company
- Amneal
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Aug 18, 2025
- FDA report date
- Sep 10, 2025
Frequently asked
- Was chlorproMAZINE Hydrochloride Tablets recalled?
- Amneal Pharmaceuticals, LLC recalled chlorproMAZINE Hydrochloride Tablets in Aug 2025 — an FDA Class II recall (D-0619-2025) because Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was chlorproMAZINE Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0619-2025 was: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Is a recalled chlorproMAZINE 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 chlorproMAZINE Hydrochloride Tablets are affected?
- Distributed: Distributed Nationwide in the USA. The recall covers these lots — Lot: AM240336, AM240337, Exp Date 02/28/2027.. 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-0619-2025.