Amneal Pharmaceuticals, LLC recalls
Every recall we track for Amneal Pharmaceuticals, LLC — 14 in all, from 2016–2026 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Amneal Pharmaceuticals, LLC more than tripled in 2025 (7, up from 1 in 2024). 31% rated “stop using now”.
All FDA recall records for Amneal Pharmaceuticals, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 1 | 0 | 0 | 0 | 1 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 2 | 0 | 5 | 0 | 7 |
| 2026 (to date) | 1 | 2 | 1 | 0 | 4 |
Amneal Pharmaceuticals, LLC recalls before 2017
Recalls on record by year.
Most common reasons for Amneal Pharmaceuticals, LLC recalls
What to do if you have a recalled Amneal Pharmaceuticals, LLC product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Amneal Pharmaceuticals, LLC recalls
10 shown- Use cautionDrug
Amneal Pharmaceuticals, LLC recalls Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater,
Amneal recalls Estradiol Gel packets due to defective containers that may be empty or partially full. Check your lot number and expiration date.
Amneal PharmaceuticalsSep 8, 2026 - Use cautionDrug
Amneal Pharmaceuticals, LLC recalls Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral
Amneal Pharmaceuticals recalls 27,936 bottles of Primidone 50mg tablets due to potential cross-contamination with Acemetacin API. Check your lot number.
Amneal PharmaceuticalsJun 3, 2026 - Lower riskDrug
Amneal Pharmaceuticals, LLC recalls traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt.
Amneal Pharmaceuticals recalls 50mg traMADol hydrochloride tablets with NDSRI impurity exceeding stability limits. This may pose health risks if used beyond expiration.
Amneal PharmaceuticalsMar 19, 2026 - Stop using nowDrug
Amneal Pharmaceuticals, LLC recalls Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV
Amneal Pharmaceuticals recalls IV magnesium sulfate bags that were mistakenly labeled as magnesium sulfate but contain tranexamic acid. This mix-up could cause serious harm if used in medical procedures.
AmnealMar 18, 2026 - Lower riskDrug
Amneal Pharmaceuticals, LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals
Amneal Pharmaceuticals recalls 200mg chlorproMAZINE tablets due to micro-organism in packaging material. No tablets were contaminated. Affected lots: AM240336, AM240337 (expiring 02/2027).
Amneal PharmaceuticalsAug 18, 2025 - Stop using nowDrug
Amneal Pharmaceuticals, LLC recalls Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b)
Amneal Pharmaceuticals recalls 400mg/80mg sulfamethoxazole and trimethoprim tablets with black spots due to microbial contamination. Stop using affected lots immediately.
AmnealJun 2, 2025 - Stop using nowDrug
Amneal Pharmaceuticals, LLC recalls Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals
Amneal Pharmaceuticals recalls 0.5% Ropivacaine Hydrochloride Injection due to particulate matter risk. Affected lots expire 01/31/2026. Contact for return instructions.
AmnealApr 17, 2025 - Lower riskDrug
Amneal Pharmaceuticals, LLC recalls Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater,
Amneal recalls 2.5mg methotrexate tablets (100-count) due to potential fludrocortisone acetate tablets inside. This could cause unintended hormone effects. Return or contact for details.
AmnealAug 1, 2024 - Stop using nowDrug
Amneal Pharmaceuticals LLC recalls Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by:
Amneal Pharmaceuticals recalls 500 mg fosphenytoin sodium injection vials due to particulate matter. This could cause serious injury if injected. Affected vials have specific NDC and lot numbers.
Amne:alAug 31, 2017 - Lower riskDrug
Amneal Pharmaceuticals LLC recalls Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC
Amneal Pharmaceuticals recalls 20mg Rabeprazole Sodium Delayed Release Tablets due to failed dissolution specifications. Rx-only tablets with specific NDC numbers and expiration dates are affected. Consumers should contact the manufacturer for details.
AmnealDec 12, 2016
Amneal Pharmaceuticals, LLC recall questions
How many recalls has Amneal Pharmaceuticals, LLC had?
14 recalls from Amneal Pharmaceuticals, LLC are on record with U.S. safety agencies, from 2016–2026.
What is the most recent Amneal Pharmaceuticals, LLC recall?
Amneal Pharmaceuticals, LLC recalls Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater,, dated Sep 8, 2026. Every Amneal Pharmaceuticals, LLC recall is listed on this page, newest first.
Why are Amneal Pharmaceuticals, LLC products recalled?
The most common reasons on record: Presence of Particulate Matter (2).
What should I do if I have a recalled Amneal Pharmaceuticals, LLC product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Amneal Pharmaceuticals, LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.