The Recall Desk

Manufacturer

Alvogen, Inc

21 recalls in our database name Alvogen, Inc as the manufacturing or recalling firm.

What the numbers show

Total
21
Critical
1
Severe
5
Most recent
2026-01-21

Of the 21 recalls from Alvogen, Inc we have scored against our rubric, 1 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (24%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–21 of 21

  • ModerateFDA (Drugs)·D-0259-2026·2026-01-21

    Carotid anesthesia kits recalled over recalled B. Braun administration sets inside

    Medline is recalling 10 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0245-2025·2025-02-26

    Fentanyl Transdermal Patches Recalled for Defective Delivery System

    Alvogen has recalled Fentanyl Transdermal System patches (25 mcg/h) nationwide due to a manufacturing defect where patches may be stacked together in a single pouch. Patients using affected lots should contact their healthcare provider.

    Product
    FENTANYL SYSTEM — FENTANYL SYSTEM (FENTANYL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0353-2023·2023-03-08

    Prescription Levothyroxine Sodium Tablets Recalled Due to Sub-Potency

    Alvogen is recalling 21,276 bottles of Levothyroxine Sodium Tablets (Lot HE02221, expiration 05/2023) distributed nationwide and in Puerto Rico due to sub-potency.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1722-2019·2019-08-21

    Alvogen Recalls Nitrofurantoin Capsules Due to Failed Dissolution Specifications

    Alvogen, Inc. is recalling 2,784 bottles of Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed to meet dissolution specifications.

    Product
    NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-1277-2019·2019-05-15

    Alvogen Recalls Fentanyl Transdermal Systems Due to Product Mix-Up

    Alvogen is recalling Fentanyl Transdermal Systems because a customer reported a carton labeled 12 mcg/h contained 50 mcg/h patches.

    Product
    FENTANYL SYSTEM — FENTANYL SYSTEM (FENTANYL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0941-2017·2017-07-12

    Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

    Alvogen, Inc. is recalling specific lots of Clindamycin Injection USP due to a lack of assurance of sterility. The recall covers 71,825 vials distributed nationwide.

    Product
    Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0940-2017·2017-07-12

    Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

    Alvogen, Inc. is recalling 72,575 vials of Clindamycin Injection USP due to a lack of assurance of sterility. The affected lots were distributed nationwide.

    Product
    Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0939-2017·2017-07-12

    Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

    Alvogen, Inc. is recalling 5,100 vials of Clindamycin Injection USP due to a lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0627-2017·2017-04-12

    Alvogen Recalls Nifedipine Extended-Release Tablets Due to Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling Nifedipine Extended-Release Tablets, 30 mg, due to cross-contamination with sorafenib powder found in the manufacturing facility's inlet air duct.

    Product
    Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0631-2017·2017-04-12

    Alvogen Recalls Nifedipine Tablets Due to Sorafenib Cross-Contamination

    Alvogen Inc. is recalling Nifedipine Extended-Release Tablets, 90 mg, due to cross-contamination with sorafenib powder found in the inlet air duct.

    Product
    Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0635-2017·2017-04-12

    Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling Adalat CC (nifedipine) 90 mg extended-release tablets because residual sorafenib powder was found in the manufacturing equipment's inlet air duct.

    Product
    Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0628-2017·2017-04-12

    Adalat CC Tablets Recalled for Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling Adalat CC (nifedipine) Extended Release Tablets 30 mg due to cross-contamination with sorafenib powder.

    Product
    Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0634-2017·2017-04-12

    Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling Adalat CC (nifedipine) 60 mg extended-release tablets because residual sorafenib powder was found in the manufacturing facility's inlet air duct.

    Product
    Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0629-2017·2017-04-12

    Adalat CC Tablets Recalled for Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling Adalat CC (nifedipine) Extended Release Tablets due to cross-contamination with sorafenib powder found in the manufacturing facility.

    Product
    Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0632-2017·2017-04-12

    Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling specific lots of Adalat CC (nifedipine) Extended-Release Tablets due to cross-contamination with sorafenib powder.

    Product
    Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0630-2017·2017-04-12

    Alvogen Recalls Nifedipine Extended-Release Tablets Due to Cross-Contamination

    Alvogen, Inc. is recalling Nifedipine Extended-Release Tablets, 60 mg, due to cross-contamination with sorafenib powder found in the manufacturing facility's inlet air duct.

    Product
    Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0633-2017·2017-04-12

    Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination

    Alvogen is recalling specific lots of Adalat CC (nifedipine) extended-release tablets due to cross-contamination with sorafenib powder.

    Product
    Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1082-2015·2015-05-20

    Alvogen Recalls Nitrofurantoin Capsules Due to Failed Dissolution Test

    Alvogen, Inc. is recalling Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed a dissolution specification test.

    Product
    NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1607-2014·2014-10-01

    Alvogen Recalls Oxycodone and Acetaminophen Tablets Due to Uniformity Failure

    Alvogen, Inc. is recalling 8,964 bottles of Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg because the lot failed uniformity of dosage units specifications for the oxycodone component.

    Product
    Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Alvogen

American Pharmaceutical Company

Founded
2009

Source: Wikidata (Q48731200), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.