Alvogen recalls
FDA enforcement reports naming Alvogen, Inc as the recalling firm.
- Recall reports
- 21
- Class I (serious)
- 2
- Most recent report
- Jan 21, 2026
- Jan 21, 2026Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactu…Drug · Alvogen, IncProduct Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.Class II
- Feb 26, 2025Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-co…Drug · Alvogen, IncDefective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.Class I
- Mar 8, 2023Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured…Drug · Alvogen, IncSub-Potent Drug: Out of specification for assay at the 24 month interval.Class II
- Jul 14, 2021Buprenorphine and Naloxone Sublingual Film 2mg/0Drug · Alvogen, IncSubpotent drug: Out of specification for assay of naloxone and buprenorphine (low)Class II
- Aug 21, 2019Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, D…Drug · Alvogen, IncFailed dissolution specificationsClass II
- Aug 21, 2019Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, MfgDrug · Alvogen, IncFailed dissolution specificationsClass II
- May 15, 2019FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Dis…Drug · Alvogen, IncProduct Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.Class I
- Jul 12, 2017Clindamycin Injection USPDrug · Alvogen, IncLack of Assurance of SterilityClass II
- Jul 12, 2017Clindamycin Injection USPDrug · Alvogen, IncLack of Assurance of SterilityClass II
- Jul 12, 2017Clindamycin Injection USPDrug · Alvogen, IncLack of Assurance of SterilityClass II
- Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured fo…
- Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Man…
- Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only M…
- Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured fo…
- Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured fo…
- Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Man…
- Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Man…
- Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Man…
- Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Man…
- NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --…
- Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only
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