Quick answers
- What is Duloxetine used for?
- The FDA-approved label (Drizalma Sprinkle, Sun Pharmaceutical Industries, Inc., May 14, 2024) says: “DRIZALMA SPRINKLE is indicated for the treatment of: • Major Depressive Disorder in adults • Generalized Anxiety Disorder in adults and pediatric patients 7 years of age and older • Diabetic Peripheral Neuropathy in adults • Fibromyalgia in adults • Chronic Musculoskeletal Pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine delayed-release capsules). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Duloxetine have a boxed warning?
- Yes. The FDA label for Drizalma Sprinkle has a boxed warning (“WARNING: SUICIDAL THOUGHTS AND BEHAVIORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Duloxetine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Duloxetine been recalled?
- FDA enforcement reports list 29 recalls of products of this medicine; the newest started June 4, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Duloxetine?
- 41 companies list prescription products of Duloxetine in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and A-S Medication Solutions.
What Duloxetine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DRIZALMA SPRINKLE is indicated for the treatment of: • Major Depressive Disorder in adults • Generalized Anxiety Disorder in adults and pediatric patients 7 years of age and older • Diabetic Peripheral Neuropathy in adults • Fibromyalgia in adults • Chronic Musculoskeletal Pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine delayed-release capsules). …
— FDA label: Drizalma Sprinkle, Sun Pharmaceutical Industries, Inc., effective May 14, 2024. Read the full label on DailyMed →
The FDA has 127 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.
This label has a boxed warning. Its heading: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
. Read it on the full label →
126 of 127 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, delayed release · Capsule, delayed release pellets |
|---|---|
| Route | Oral |
| Prescription products | 205 in the FDA NDC Directory |
| Brand names | Drizalma Sprinkle |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| duloxetine hydrochloride 120 mg capsule, delayed release | Generic | $5.66 per capsule |
| duloxetine hydrochloride 20 mg capsule, delayed release | Generic | $0.1179 per capsule |
| duloxetine hydrochloride 20 mg capsule, delayed release | Brand: Drizalma Sprinkle | $7.07 per capsule |
| duloxetine hydrochloride 20 mg capsule, delayed release pellets | Generic | $0.1179 per capsule |
| duloxetine hydrochloride 30 mg capsule, delayed release | Generic | $0.0994 per capsule |
| duloxetine hydrochloride 30 mg capsule, delayed release | Brand: Drizalma Sprinkle | $7.27 per capsule |
| duloxetine hydrochloride 30 mg capsule, delayed release pellets | Generic | $0.0994 per capsule |
| duloxetine hydrochloride 40 mg capsule, delayed release | Generic | $1.21 per capsule |
| duloxetine hydrochloride 40 mg capsule, delayed release | Brand: Drizalma Sprinkle | $7.16 per capsule |
| duloxetine hydrochloride 40 mg capsule, delayed release pellets | Generic | $1.21 per capsule |
| duloxetine hydrochloride 60 mg capsule, delayed release | Generic | $0.1368 per capsule |
| duloxetine hydrochloride 60 mg capsule, delayed release | Brand: Drizalma Sprinkle | $7.15 per capsule |
| duloxetine hydrochloride 60 mg capsule, delayed release pellets | Generic | $0.1368 per capsule |
| duloxetine hydrochloride 90 mg capsule, delayed release | Generic | $5.65 per capsule |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 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.
- Bryant Ranch Prepack25 products
- Proficient Rx LP11 products
- A-S Medication Solutions11 products
- Remedyrepack Inc.9 products
- Aphena Pharma Solutions - Tennessee, LLC9 products
- Quallent Pharmaceuticals Health LLC8 products
- Preferred Pharmaceuticals Inc.8 products
- Asclemed USA, Inc.8 products
- Sun Pharmaceutical Industries, Inc.7 products
- NuCare Pharmaceuticals, Inc.7 products
- Hawaii Repack, Inc.7 products
- Golden State Medical Supply, Inc.7 products
- BluePoint Laboratories5 products
- Advanced Rx of Tennessee, LLC5 products
- Ajanta Pharma USA Inc.4 products
- Direct_Rx4 products
- Breckenridge Pharmaceutical, Inc.4 products
- Lupin Pharmaceuticals, Inc.4 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- Camber Pharmaceuticals, Inc.3 products
- ANI Pharmaceuticals, Inc.3 products
- Advanced Rx Pharmacy of Tennessee, LLC3 products
- Macleods Pharmaceuticals Limited3 products
- Inventia Healthcare Limited.3 products
- Yaopharma Co., Ltd.3 products
- Aurobindo Pharma Limited3 products
- Alembic Pharmaceuticals Inc.3 products
- Qingdao BAHEAL Pharmaceutical Co., Ltd.3 products
- Marksans Pharma Limited3 products
- Solco Healthcare US, LLC3 products
- Alembic Pharmaceuticals Limited3 products
- Almatica Pharma LLC3 products
- St. Mary's Medical Park Pharmacy3 products
- Zydus Lifesciences Limited3 products
- Ascend Laboratories, LLC3 products
- Coupler LLC3 products
- Actavis Pharma, Inc.3 products
- Preferred Phamaceuticals Inc.2 products
- Northwind Health Company, LLC1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- QPharma, Inc.1 product
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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA212516 DRIZALMA SPRINKLE | Sun Pharm | July 19, 2019 | 3, latest August 18, 2023 2023: Labeling · 2021: Efficacy · 2020: Labeling |
| NDA219131 DULOXETINE HYDROCHLORIDE | Almatica | February 27, 2026 | 1, latest August 17, 2026 2026: Labeling |
Generic approvals (16)
- ANDA090694Lupin · December 11, 2013
- ANDA090723Pharmazone · December 11, 2013
- ANDA090745Sun Pharm · December 11, 2013
- ANDA090778Aurobindo Pharma Ltd · December 11, 2013
- ANDA090776Actavis Elizabeth · December 17, 2013
- ANDA090739Zydus Hlthcare · January 8, 2014
- ANDA202949Alembic · June 9, 2014
- ANDA203088Breckenridge · June 11, 2014
- ANDA203197Alkem Labs Ltd · August 26, 2015
- ANDA202336Inventia · October 28, 2015
- ANDA204343Hetero Labs Ltd III · August 3, 2016
- ANDA208706Ajanta Pharma Ltd · January 6, 2017
- ANDA204815Macleods Pharms · March 23, 2017
- ANDA206653Prinston Inc · May 18, 2017
- ANDA210599Qingdao Baheal Pharm · April 17, 2019
- ANDA207219Yaopharma Co Ltd · August 16, 2019
Shortage status
The FDA drug shortage list does not show these products.
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.
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June 4, 2026 · Class II · Ongoing · D-0583-2026
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by — Breckenridge Pharmaceutical, Inc.
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June 4, 2026 · Class II · Ongoing · D-0582-2026
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berke — Breckenridge Pharmaceutical, Inc.
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May 14, 2026 · Class II · Ongoing · D-0555-2026
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc. — Asclemed USA Inc.
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April 29, 2026 · Class II · Ongoing · D-0514-2026
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Mad — Ajanta Pharma Ltd.
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April 29, 2026 · Class II · Ongoing · D-0516-2026
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06. — Ajanta Pharma Ltd.
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April 29, 2026 · Class II · Ongoing · D-0515-2026
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03 — Ajanta Pharma Ltd.
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April 21, 2026 · Class II · Ongoing · D-0522-2026
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, N — Breckenridge Pharmaceutical, Inc.
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November 24, 2025 · Class II · Ongoing · D-0216-2026
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkel — Breckenridge Pharmaceutical, Inc.
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November 24, 2025 · Class II · Ongoing · D-0215-2026
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC — Breckenridge Pharmaceutical, Inc.
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October 9, 2025 · Class II · Ongoing · D-0100-2026
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. — Breckenridge Pharmaceutical, Inc.
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August 8, 2025 · Class II · Ongoing · D-0621-2025
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health L — Breckenridge Pharmaceutical, Inc.
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July 25, 2025 · Class II · Ongoing · D-0580-2025
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health L — Breckenridge Pharmaceutical, Inc.
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July 15, 2025 · Class II · Ongoing · D-0552-2025
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Height — Breckenridge Pharmaceutical, Inc.
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June 30, 2025 · Class II · Ongoing · D-0511-2025
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 079 — Breckenridge Pharmaceutical, Inc.
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April 14, 2025 · Class II · Ongoing · D-0387-2025
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-1 — Breckenridge Pharmaceutical, Inc
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April 14, 2025 · Class II · Ongoing · D-0388-2025
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge P — Breckenridge Pharmaceutical, Inc
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March 26, 2025 · Class II · Ongoing · D-0308-2025
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., — Breckenridge Pharmaceutical, Inc.
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February 28, 2025 · Class II · Ongoing · D-0271-2025
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07 — Breckenridge Pharmaceutical, Inc.
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February 28, 2025 · Class II · Ongoing · D-0269-2025
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 0 — Breckenridge Pharmaceutical, Inc.
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February 28, 2025 · Class II · Ongoing · D-0270-2025
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 0 — Breckenridge Pharmaceutical, Inc.
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December 6, 2024 · Class II · Ongoing · D-0162-2025
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berke — Breckenridge Pharmaceutical, Inc
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December 6, 2024 · Class II · Ongoing · D-0161-2025
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkel — Breckenridge Pharmaceutical, Inc
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October 10, 2024 · Class II · Completed · D-0009-2025
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05. — Breckenridge Pharmaceutical, Inc
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May 17, 2024 · Class II · Terminated · D-0562-2024
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 0792 — Breckenridge Pharmaceutical, Inc
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April 29, 2024 · Class II · Ongoing · D-0484-2024
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07 — Breckenridge Pharmaceutical, Inc
Showing the newest 25 of 29.
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Drizalma Sprinkle, Sun Pharmaceutical Industries, Inc., effective May 14, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →