Amneal Pharmaceuticals, LLC 2025-09-10 Health serious FDA
Health · FDA · Recall #FDA-D-0616-2025
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only,… Recall
Issued September 10, 2025 · Amneal Pharmaceuticals, LLC
In September 2025, Amneal Pharmaceuticals, LLC recalled the chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Amneal Pharmaceuticals, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Amneal Pharmaceuticals, LLC
- Category
- Health
- Recall date
- September 10, 2025
- Units affected
- Not reported
- Sold at
- Distributed Nationwide in the USA
- Recall number
- FDA-D-0616-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Amneal Pharmaceuticals, LLC has 6 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.