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Buprenorphine and naloxone

Also listed by the FDA as: buprenorphine hydrochloride / naloxone hydrochloride dihydrate · buprenorphine hydrochloride / naloxone hydrochloride · buprenorphine / naloxone · buprenorphine hydrochloride / naloxone

Drug class: Opioid Antagonist, Partial Opioid Agonist

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Buprenorphine and naloxone key facts

Drug class
Opioid Antagonist
Used for
Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. (source)
Prescription or over the counter
Prescription (Rx)
Generic available
Yes
Typical pharmacy cost
$0.5390 per tablet (buprenorphine hydrochloride 2 mg · naloxone hydrochloride dihydrate 0.5 mg; NADAC)
Latest FDA recall
October 18, 2022 (Class II)

Sources: FDA label (July 26, 2026); FDA NDC Directory (October 30, 2026); CMS NADAC (November 4, 2026); FDA enforcement reports (October 27, 2026). Not medical advice.

Quick answers

What is Buprenorphine and naloxone used for?
The FDA-approved label (Buprenorphine and Naloxone, Hikma Pharmaceuticals USA Inc., July 26, 2026) says: “Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
What are the side effects of Buprenorphine and naloxone?
The “Adverse Reactions” section of the FDA label (Buprenorphine and Naloxone, Hikma Pharmaceuticals USA Inc., July 26, 2026) begins: “The following serious adverse reactions are described elsewhere in the labeling: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] • Respiratory and CNS Depression [see Warnings and Precautions (5.2, 5.3)] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)] • Adrenal Insufficiency [see Warnings and Precautions (5.6)] • Opioid Withdrawal [see Warnings and Precautions (5.7, 5.10)] • Hepatitis, Hepatic Events [see Warnings and …” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
What are the drug interactions of Buprenorphine and naloxone?
The “Drug Interactions” section of the FDA label (Buprenorphine and Naloxone, Hikma Pharmaceuticals USA Inc., July 26, 2026) begins: “Table 3 includes clinically significant drug interactions with Buprenorphine and Naloxone Sublingual Tablets. Table 3.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Buprenorphine and naloxone have a boxed warning?
No. None of the 53 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Buprenorphine and naloxone?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Buprenorphine and naloxone been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started October 18, 2022 (Class II). A recall usually concerns specific lots, not every product.
Who makes Buprenorphine and naloxone?
29 companies list prescription products of Buprenorphine and naloxone in the FDA NDC Directory, including Bryant Ranch Prepack, Redpharm Drug and Camber Pharmaceuticals, Inc.

What Buprenorphine and naloxone is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. …

— FDA label: Buprenorphine and Naloxone, Hikma Pharmaceuticals USA Inc., effective July 26, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, sublingual), Buprenorphine and Naloxone, Hikma Pharmaceuticals USA Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 53 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 53 FDA labels for this medicine have a boxed warning.

Buprenorphine and naloxone side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following serious adverse reactions are described elsewhere in the labeling:

  • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)]
  • Respiratory and CNS Depression [see Warnings and Precautions (5.2, 5.3)]
  • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)]
  • Adrenal Insufficiency [see Warnings and Precautions (5.6)]
  • Opioid Withdrawal [see Warnings and Precautions (5.7, 5.10)]
  • Hepatitis, Hepatic Events [see Warnings and …

— FDA label: Buprenorphine and Naloxone, Hikma Pharmaceuticals USA Inc., effective July 26, 2026. This is part of the section. Read the full label on DailyMed →

Buprenorphine and naloxone drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Table 3 includes clinically significant drug interactions with Buprenorphine and Naloxone Sublingual Tablets. Table 3.

Read more of this section

Clinically Significant Drug Interactions with Buprenorphine and Naloxone Sublingual Tablets Benzodiazepines or Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. Intervention: Cessation of benzodiazepines or other CNS depressants is preferred in most cases of concomitant use. In some cases, monitoring in a higher level of care for taper may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or decreasing to the lowest effective dose may be appropriate. Before co-prescribing benzodiazepines for anxiety or insomnia, ensure that patients are appropriately diagnosed and consider alternative medications and non-pharmacologic treatments [see Warnings and Precautions (5.2, 5.3)]. If concomitant use is warranted, strongly consider recommending or prescribing an opioid overdose reversal agent, as is recommended for all patients on buprenorphine treatment for opioid use disorder [see Warnings and Precautions (5.2)]. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. Inhibitors of CYP3A4 Clinical Impact: The concomitant use of buprenorphine and CYP3A4 inhibitors can increase the plasma concentration of buprenorphine, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of Buprenorphine and Naloxone Sublingual Tablets is achieved. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the buprenorphine plasma concentration will decrease [see Clinical Pharmacology (12.3)], potentially resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to buprenorphine. Intervention: If concomitant use is necessary, consider dosage reduction of Buprenorphine and Naloxone Sublingual Tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the Buprenorphine and Naloxone Sublingual Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir).

— FDA label: Buprenorphine and Naloxone, Hikma Pharmaceuticals USA Inc., effective July 26, 2026. This is part of the section. Read the full label on DailyMed →

Buprenorphine and naloxone dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

  • Administer Buprenorphine and Naloxone Sublingual Tablets sublingually as a single daily dose. (2.1)
  • Strongly consider recommending or prescribing an opioid overdose reversal agent (e.g., naloxone, nalmefene) at the time Buprenorphine and Naloxone Sublingual Tablets are initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose.
Read more of this section

(2.2)

  • To avoid precipitating withdrawal, induction with Buprenorphine Sublingual Tablets should be undertaken when objective and clear signs of withdrawal are evident. After induction, doses of Buprenorphine and Naloxone Sublingual Tablets should be progressively adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms. (2.3)
  • The maintenance dose of Buprenorphine and Naloxone Sublingual Tablets is generally in the range of 4 mg/1 mg to 24 mg/6 mg per day and should be based on clinical response. (2.3)
  • Administer Buprenorphine and Naloxone Sublingual Tablets as directed in the Full Prescribing Information. (2.3, 2.4)
  • When discontinuing treatment, gradually taper to avoid signs and symptoms of withdrawal. (2.7) 2.1 Important Dosage and Administration Information Buprenorphine and Naloxone Sublingual Tablets are administered sublingually as a single daily dose. Buprenorphine and Naloxone Sublingual Tablets should be used in patients who have been initially inducted using buprenorphine sublingual tablets. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits. 2.2 Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene) and discuss the importance of having access to an opioid overdose reversal agent. Because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose, strongly consider recommending or prescribing an overdose reversal agent for the emergency treatment of opioid overdose, both when initiating and renewing treatment with Buprenorphine and Naloxone Sublingual Tablets. Also consider recommending or prescribing such an agent if the patient has household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose [see Warnings and Precautions (5.2)]. Discuss the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program) [see Warnings and Precautions (5.2)]. There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics. Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent.

— FDA label: Buprenorphine and Naloxone, Hikma Pharmaceuticals USA Inc., effective July 26, 2026. This is part of the section. Read the full label on DailyMed →

Buprenorphine and naloxone in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary The data on use of buprenorphine, one of the active ingredients in Buprenorphine and Naloxone Sublingual Tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. There are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see Data].

Read more of this section

Observational studies have reported on congenital malformations among buprenorphine‐exposed pregnancies, but were also not designed appropriately to assess the risk of congenital malformations specifically due to buprenorphine exposure [see Data]. The extremely limited data on sublingual naloxone exposure in pregnancy are not sufficient to evaluate a drug‐associated risk. Reproductive and developmental studies in rats and rabbits identified adverse events at clinically relevant and higher doses. Embryo-fetal death was observed in both rats and rabbits administered buprenorphine during the period of organogenesis at doses approximately 6 and 0.3 times, respectively, the human sublingual dose of 16 mg/day of buprenorphine. Pre- and post-natal development studies in rats demonstrated increased neonatal deaths at 0.3 times and above and dystocia at approximately 3 times the human sublingual dose of 16 mg/day of buprenorphine. No clear teratogenic effects were seen when buprenorphine was administered during organogenesis with a range of doses equivalent to or greater than the human sublingual dose of 16 mg/day of buprenorphine. However, increases in skeletal abnormalities were noted in rats and rabbits administered buprenorphine daily during organogenesis at doses approximately 0.6 times and approximately equal to the human sublingual dose of 16 mg/day of buprenorphine, respectively. In a few studies, some events such as acephalus and omphalocele were also observed but these findings were not clearly treatment-related [see Data]. Based on animal data, advise pregnant women of the potential risk to a fetus. The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and embryo-fetal risk Untreated opioid addiction in pregnancy is associated with adverse obstetrical outcomes such as low birth weight, preterm birth, and fetal death. In addition, untreated opioid addiction often results in continued or relapsing illicit opioid use. Dose Adjustment during Pregnancy and the Postpartum Period Dosage adjustments of buprenorphine, such as using higher doses, may be required during pregnancy, even if the patient was maintained on a stable dose prior to pregnancy. Dosing should be based on individual response, and withdrawal signs and symptoms should be monitored closely and the dose adjusted as necessary.

— FDA label: Buprenorphine and Naloxone, Hikma Pharmaceuticals USA Inc., effective July 26, 2026. This is part of the section. Read the full label on DailyMed →

When Buprenorphine and naloxone should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Buprenorphine and Naloxone Sublingual Tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.9)]. Hypersensitivity to buprenorphine or naloxone. (4)

— FDA label: Buprenorphine and Naloxone, Hikma Pharmaceuticals USA Inc., effective July 26, 2026. Read the full label on DailyMed →

Buprenorphine and naloxone overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Clinical Presentation The manifestations of acute overdose include pinpoint pupils, sedation, hypotension, hypoglycemia, respiratory depression, and death. Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication. Treatment of Overdose In the event of overdose, the respiratory and cardiac status of the patient should be monitored carefully.

Read more of this section

When respiratory or cardiac functions are depressed, primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Oxygen, IV fluids, vasopressors, and other supportive measures should be employed as indicated. In the case of overdose, the primary management should be the re-establishment of adequate ventilation with mechanical assistance of respiration, if required. An opioid overdose reversal agent may be of value for the management of buprenorphine overdose. Higher than normal doses and repeated administration may be necessary. The long duration of action of Buprenorphine and Naloxone Sublingual Tablets should be taken into consideration when determining the length of treatment and medical surveillance needed to reverse the effects of an overdose. Insufficient duration of monitoring may put patients at risk.

— FDA label: Buprenorphine and Naloxone, Hikma Pharmaceuticals USA Inc., effective July 26, 2026. Read the full label on DailyMed →

Forms and how it is given

Dosage formsTablet · Film · Film, soluble · Tablet, orally disintegrating
RouteSublingual · Buccal
Prescription products102 in the FDA NDC Directory
Brand namesZubsolv, Buprenorphine and Naloxone Sublingual Film, Suboxone

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Buprenorphine and naloxone, by strength and form
Strength and formGeneric or brandPharmacies pay
buprenorphine 2 mg · naloxone 0.5 mg
tablet
Generic $0.5390 per tablet
buprenorphine 8 mg · naloxone 2 mg
tablet
Generic $0.7172 per tablet
buprenorphine hydrochloride 0.7 mg · naloxone hydrochloride 0.18 mg
tablet, orally disintegrating
Brand: Zubsolv $5.26 per tablet
buprenorphine hydrochloride 1.4 mg · naloxone hydrochloride 0.36 mg
tablet, orally disintegrating
Brand: Zubsolv $5.26 per tablet
buprenorphine hydrochloride 11.4 mg · naloxone hydrochloride 2.9 mg
tablet, orally disintegrating
Brand: Zubsolv $21.05 per tablet
buprenorphine hydrochloride 12 mg · naloxone 3 mg
film, soluble
Generic $4.27 per unit
buprenorphine hydrochloride 12 mg · naloxone hydrochloride 3 mg
film
Generic $4.27 per unit
buprenorphine hydrochloride 12 mg · naloxone hydrochloride 3 mg
film, soluble
Brand: Suboxone $17.16 per unit
buprenorphine hydrochloride 12 mg · naloxone hydrochloride dihydrate 3 mg
film
Generic $4.27 per unit
buprenorphine hydrochloride 2 mg · naloxone 0.5 mg
film, soluble
Generic $1.39 per unit
buprenorphine hydrochloride 2 mg · naloxone hydrochloride 0.5 mg
film
Generic $1.39 per unit
buprenorphine hydrochloride 2 mg · naloxone hydrochloride 0.5 mg
film, soluble
Brand: Suboxone $4.78 per unit
buprenorphine hydrochloride 2 mg · naloxone hydrochloride 0.5 mg
tablet
Generic $0.5390 per tablet
buprenorphine hydrochloride 2 mg · naloxone hydrochloride dihydrate 0.5 mg
film
Generic $1.39 per unit
buprenorphine hydrochloride 2 mg · naloxone hydrochloride dihydrate 0.5 mg
tablet
Generic $0.5390 per tablet
buprenorphine hydrochloride 2.9 mg · naloxone hydrochloride 0.71 mg
tablet, orally disintegrating
Brand: Zubsolv $10.52 per tablet
buprenorphine hydrochloride 4 mg · naloxone 1 mg
film, soluble
Generic $2.54 per unit
buprenorphine hydrochloride 4 mg · naloxone hydrochloride 1 mg
film
Generic $2.54 per unit
buprenorphine hydrochloride 4 mg · naloxone hydrochloride 1 mg
film, soluble
Brand: Suboxone $8.58 per unit
buprenorphine hydrochloride 4 mg · naloxone hydrochloride dihydrate 1 mg
film
Generic $2.54 per unit
buprenorphine hydrochloride 5.7 mg · naloxone hydrochloride 1.4 mg
tablet, orally disintegrating
Brand: Zubsolv $10.54 per tablet
buprenorphine hydrochloride 8 mg · naloxone 2 mg
film, soluble
Generic $1.95 per unit
buprenorphine hydrochloride 8 mg · naloxone hydrochloride 2 mg
film
Generic $1.95 per unit
buprenorphine hydrochloride 8 mg · naloxone hydrochloride 2 mg
film, soluble
Brand: Suboxone $8.59 per unit
buprenorphine hydrochloride 8 mg · naloxone hydrochloride 2 mg
tablet
Generic $0.7172 per tablet
buprenorphine hydrochloride 8 mg · naloxone hydrochloride dihydrate 2 mg
film
Generic $1.95 per unit
buprenorphine hydrochloride 8 mg · naloxone hydrochloride dihydrate 2 mg
tablet
Generic $0.7172 per tablet
buprenorphine hydrochloride 8.6 mg · naloxone hydrochloride 2.1 mg
tablet, orally disintegrating
Brand: Zubsolv $15.81 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA022410
SUBOXONE
IndiviorAugust 30, 2010 40, latest August 14, 2026
2026: REMS · 2025: Labeling · 2025: Labeling
NDA204242
ZUBSOLV
Edenbridge PharmsJuly 3, 2013 26, latest August 14, 2026
2026: REMS · 2025: Labeling · 2025: Labeling

Generic approvals (18)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. October 18, 2022 · Class II · Terminated · D-0024-2023

    Presence of Foreign Substance

    Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 25 — SUN PHARMACEUTICAL INDUSTRIES INC

  2. February 26, 2021 · Class II · Terminated · D-0649-2021

    Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)

    Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03 — Alvogen, Inc

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)351266, 351267, 1010600, 1010603, 1010604, 1010606, 1307056, 1307058, 1307061, 1307063 … (+10)
SPL set ID of the quoted label713db2c6-0544-4633-b874-cfbeaf93db89
FDA labels (SPL)53
FDA applicationsNDA022410, NDA204242, 18 ANDA
Active ingredients (FDA)BUPRENORPHINE / NALOXONE

Next steps

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Buprenorphine and Naloxone, Hikma Pharmaceuticals USA Inc., effective July 26, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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