Amneal Pharmaceuticals recalls
FDA enforcement reports naming Amneal Pharmaceuticals as the recalling firm.
- Recall reports
- 24
- Class I (serious)
- 3
- Most recent report
- Jun 17, 2026
- Jun 17, 2026Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal…Drug · Amneal Pharmaceuticals, LLCCross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.Class III
- Apr 8, 2026Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged…Drug · Amneal Pharmaceuticals, LLCProduct mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.Class I
- Apr 8, 2026traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured b…Drug · Amneal Pharmaceuticals, LLCFailed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).Class II
- Sep 10, 2025chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufact…Drug · Amneal Pharmaceuticals, LLCPresence 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.Class II
- Sep 10, 2025chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactu…Drug · Amneal Pharmaceuticals, LLCPresence 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.Class II
- Sep 10, 2025chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactur…Drug · Amneal Pharmaceuticals, LLCPresence 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.Class II
- Sep 10, 2025Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, P…Drug · Amneal Pharmaceuticals, LLCPresence 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.Class II
- Sep 10, 2025chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactu…Drug · Amneal Pharmaceuticals, LLCPresence 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.Class II
- Jun 18, 2025Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets p…Drug · Amneal Pharmaceuticals, LLCMicrobial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.Class I
- May 14, 2025Ropivacaine Hydrochloride Injection, USP, 0Drug · Amneal Pharmaceuticals, LLCPresence of Particulate MatterClass I
- Methotrexate Tablets, USP, 2
- Ranitidine Tablets, USP 300 mg - a)
- Ranitidine Tablets, USP 150 mg a)
- Ranitidine Tablets, USP 150 mg, 1000-count bottles
- Ranitidine Syrup Oral Solution 15 mg/mL 6
- Ranitidine Tablets, USP 300 mg, 250-count bottles
- Isotretinoin Capsules, USP 10 mg
- Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Ph…
- Methylergonovine Maleate USP 0
- Esterified Estrogens & Methyltestosterone Tablets, USP 0
- Esterified Estrogens & Methyltestosterone Tablets, USP 1
- Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India
- Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL
- Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-0…
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