Amneal Pharmaceuticals recalls
Amneal Pharmaceuticals appears in 52 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-07.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 52 |
|---|---|
| Published | 2013-11-13 to 2026-10-07 |
| By agency | FDA Drug (52) |
| By classification | Class II (39), Class III (8), Class I (5) |
| By status | ongoing (29), terminated (21), completed (2) |
| Distribution named in notices | IL, LA, MS, NC, NH, NJ, NY, OH, PA, RI, TN, TX, US, UT |
Recalls
- Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-…
FDA Drug · Class II · 2026-10-07 · Amneal Pharmaceuticals
Reason: Defective Container; packets were found to be either empty or partially full. - Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured b…
FDA Drug · Class II · 2026-09-30 · Amneal Pharmaceuticals
Reason: Defective Delivery System: Possibility of no medication in the prefilled pen. - Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class III · 2026-06-17 · Amneal Pharmaceuticals
Reason: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. - traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class II · 2026-04-08 · Amneal Pharmaceuticals
Reason: Failed 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). - Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufact…
FDA Drug · Class I · 2026-04-08 · Amneal Pharmaceuticals
Reason: Product 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. - chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class II · 2025-09-10 · Amneal Pharmaceuticals
Reason: 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. - chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class II · 2025-09-10 · Amneal Pharmaceuticals
Reason: 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. - Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10
FDA Drug · Class II · 2025-09-10 · Amneal Pharmaceuticals
Reason: 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. - chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class II · 2025-09-10 · Amneal Pharmaceuticals
Reason: 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. - chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class II · 2025-09-10 · Amneal Pharmaceuticals
Reason: 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. - Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bot…
FDA Drug · Class I · 2025-06-18 · Amneal Pharmaceuticals
Reason: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. - Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class I · 2025-05-14 · Amneal Pharmaceuticals
Reason: Presence of Particulate Matter - Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-…
FDA Drug · Class III · 2024-08-14 · Amneal Pharmaceuticals
Reason: Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle. - Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807,…
FDA Drug · Class II · 2024-05-08 · Amneal Pharmaceuticals
Reason: Failed Dissolution Specifications - Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3
FDA Drug · Class I · 2024-04-24 · Amneal Pharmaceuticals
Reason: Superpotent Drug: Due to overfilling of drug powder - Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class II · 2024-04-03 · Amneal Pharmaceuticals
Reason: Failed dissolution specifications - Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgew…
FDA Drug · Class II · 2024-02-28 · Amneal Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: Out-of-specification test results. - Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class II · 2024-02-14 · Amneal Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. - Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 6…
FDA Drug · Class II · 2023-11-15 · Amneal Pharmaceuticals
Reason: Failed Dissolution Specifications - Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater…
FDA Drug · Class II · 2023-06-21 · Amneal Pharmaceuticals
Reason: Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification) - Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for In…
FDA Drug · Class III · 2023-05-31 · Amneal Pharmaceuticals
Reason: Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 701… - Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, In…
FDA Drug · Class II · 2022-08-31 · Amneal Pharmaceuticals
Reason: Failed dissolution specifications. - Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 088…
FDA Drug · Class II · 2021-11-24 · Amneal Pharmaceuticals
Reason: Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. - Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08…
FDA Drug · Class II · 2021-11-24 · Amneal Pharmaceuticals
Reason: Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. - amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals L…
FDA Drug · Class II · 2020-07-01 · Amneal Pharmaceuticals
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals…
FDA Drug · Class II · 2020-07-01 · Amneal Pharmaceuticals
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53…
FDA Drug · Class II · 2020-07-01 · Amneal Pharmaceuticals
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals…
FDA Drug · Class II · 2020-07-01 · Amneal Pharmaceuticals
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Brid…
FDA Drug · Class II · 2020-07-01 · Amneal Pharmaceuticals
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LL…
FDA Drug · Class II · 2020-07-01 · Amneal Pharmaceuticals
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class II · 2020-07-01 · Amneal Pharmaceuticals
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class II · 2020-07-01 · Amneal Pharmaceuticals
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LL…
FDA Drug · Class II · 2020-07-01 · Amneal Pharmaceuticals
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 088…
FDA Drug · Class II · 2020-07-01 · Amneal Pharmaceuticals
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC…
FDA Drug · Class II · 2020-07-01 · Amneal Pharmaceuticals
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals…
FDA Drug · Class II · 2020-07-01 · Amneal Pharmaceuticals
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 N…
FDA Drug · Class II · 2020-05-06 · Amneal Pharmaceuticals
Reason: CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. - Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10
FDA Drug · Class II · 2019-12-18 · Amneal Pharmaceuticals
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API - Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02
FDA Drug · Class II · 2019-12-18 · Amneal Pharmaceuticals
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API - Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles…
FDA Drug · Class II · 2019-12-18 · Amneal Pharmaceuticals
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API - Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90
FDA Drug · Class II · 2019-12-18 · Amneal Pharmaceuticals
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API - Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC…
FDA Drug · Class II · 2019-12-18 · Amneal Pharmaceuticals
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API - Isotretinoin Capsules, USP 10 mg
FDA Drug · Class III · 2019-11-20 · Amneal Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. - Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
FDA Drug · Class III · 2019-10-16 · Amneal Pharmaceuticals
Reason: Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle - Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
FDA Drug · Class III · 2019-07-31 · Amneal Pharmaceuticals
Reason: Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets - Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals…
FDA Drug · Class III · 2019-07-10 · Amneal Pharmaceuticals
Reason: Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets. - Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceutical…
FDA Drug · Class III · 2019-07-10 · Amneal Pharmaceuticals
Reason: Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets. - Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India
FDA Drug · Class II · 2018-04-04 · Amneal Pharmaceuticals
Reason: Presence of particulate matter - Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876
FDA Drug · Class I · 2017-12-27 · Amneal Pharmaceuticals
Reason: Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. - Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only
FDA Drug · Class II · 2017-11-22 · Amneal Pharmaceuticals
Reason: Presence of Particulate Matter