Amneal Pharmaceuticals, LLC: 13 recalls on record

Recalls filed with 1 agency: FDA (13).

First recall on record: May 10, 2017. Most recent: June 17, 2026.

Risk classification: Class I: 3 · Class II: 8 · Class III: 2

Most recent recalls

DateAgencyProduct
June 17, 2026FDAPrimidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal P…D-0585-2026
April 8, 2026FDAtraMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by:…D-0408-2026
April 8, 2026FDAMagnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in…D-0478-2026
September 10, 2025FDAchlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufacture…D-0616-2025
September 10, 2025FDAchlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufacture…D-0619-2025
September 10, 2025FDASulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Pac…D-0615-2025
September 10, 2025FDAchlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured…D-0617-2025
September 10, 2025FDAchlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactur…D-0618-2025
June 18, 2025FDASulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per…D-0488-2025
May 14, 2025FDARopivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured …D-0402-2025
August 14, 2024FDAMethotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharm…D-0629-2024
November 22, 2017FDAFosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vi…D-0076-2018
May 10, 2017FDARabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03)…D-0693-2017

Questions about this company

How many recalls does Amneal Pharmaceuticals, LLC have?
Recalert has 13 U.S. recalls on record for Amneal Pharmaceuticals, LLC, published between May 10, 2017 and June 17, 2026.
What was the most recent Amneal Pharmaceuticals, LLC recall?
FDA recall D-0585-2026, published June 17, 2026: Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuti…
Which agencies have handled Amneal Pharmaceuticals, LLC recalls?
Amneal Pharmaceuticals, LLC appears as the recalling firm in recalls from: FDA (13).

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