Quick answers
- What is Doxycycline used for?
- The FDA-approved label (Acticlate CAP, Aqua Pharmaceuticals, November 28, 2017) says: “ACTICLATE ® and ACTICLATE ® CAP are tetracycline class drugs indicated for: Rickettsial infections Sexually transmitted infections Respiratory tract infections Specific bacterial infections Ophthalmic infections Anthrax, including inhalational anthrax (post-exposure) Alternative treatment for selected infections when penicillin is contraindicated Adjunctive therapy for acute intestinal amebiasis and severe acne …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Doxycycline have a boxed warning?
- No. None of the 236 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Doxycycline?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated July 30, 2026). Ask your pharmacist about alternatives.
- Has Doxycycline been recalled?
- FDA enforcement reports list 15 recalls of products of this medicine; the newest started September 29, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Doxycycline?
- 82 companies list prescription products of Doxycycline in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Proficient Rx LP.
What Doxycycline is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ACTICLATE ® and ACTICLATE ® CAP are tetracycline class drugs indicated for: Rickettsial infections Sexually transmitted infections Respiratory tract infections Specific bacterial infections Ophthalmic infections Anthrax, including inhalational anthrax (post-exposure) Alternative treatment for selected infections when penicillin is contraindicated Adjunctive therapy for acute intestinal amebiasis and severe acne …
— FDA label: Acticlate CAP, Aqua Pharmaceuticals, effective November 28, 2017. Read the full label on DailyMed →
The FDA has 236 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.
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 236 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Tablet, film coated · Tablet · Injection, powder, lyophilized, for solution · Tablet, delayed release · Tablet, coated · Powder, for suspension · Injection, powder, for solution · For suspension |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 332 in the FDA NDC Directory |
| Brand names | Doxy 100, Acticlate Cap, Doryx Mpc, Doxycyclate Hyclate, Targadox, Oracea |
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 |
|---|---|---|
| doxycycline 100 mg capsule | Generic | $0.2244 per capsule |
| doxycycline 100 mg tablet | Generic | $0.2577 per tablet |
| doxycycline 100 mg tablet, film coated | Generic | $0.2577 per tablet |
| doxycycline 150 mg tablet | Generic | $0.6017 per tablet |
| doxycycline 150 mg tablet, film coated | Generic | $0.6017 per tablet |
| doxycycline 25 mg/5 mL for suspension | Generic | $0.2295 per mL |
| doxycycline 25 mg/5 mL powder, for suspension | Generic | $0.2295 per mL |
| doxycycline 40 mg capsule | Generic | $4.86 per capsule |
| doxycycline 40 mg capsule | Brand: Oracea | $29.04 per capsule |
| doxycycline 50 mg capsule | Generic | $0.1474 per capsule |
| doxycycline 50 mg tablet | Generic | $0.1573 per tablet |
| doxycycline 50 mg tablet, film coated | Generic | $0.1573 per tablet |
| doxycycline 75 mg tablet | Generic | $0.2949 per tablet |
| doxycycline 75 mg tablet, film coated | Generic | $0.2949 per tablet |
| doxycycline hyclate 100 mg capsule | Generic | $0.1079 per capsule |
| doxycycline hyclate 100 mg tablet | Generic | $0.1200 per tablet |
| doxycycline hyclate 100 mg tablet, coated | Generic | $0.1200 per tablet |
| doxycycline hyclate 100 mg tablet, delayed release | Generic | $2.16 per tablet |
| doxycycline hyclate 100 mg tablet, film coated | Generic | $0.1200 per tablet |
| doxycycline hyclate 150 mg tablet | Generic | $0.7169 per tablet |
| doxycycline hyclate 150 mg tablet, coated | Generic | $0.7169 per tablet |
| doxycycline hyclate 150 mg tablet, film coated | Generic | $0.7169 per tablet |
| doxycycline hyclate 20 mg tablet | Generic | $0.1043 per tablet |
| doxycycline hyclate 20 mg tablet, film coated | Generic | $0.1043 per tablet |
| doxycycline hyclate 200 mg tablet, delayed release | Generic | $5.89 per tablet |
| doxycycline hyclate 50 mg capsule | Generic | $0.1496 per capsule |
| doxycycline hyclate 50 mg tablet | Generic | $4.39 per tablet |
| doxycycline hyclate 50 mg tablet, delayed release | Generic | $1.57 per tablet |
| doxycycline hyclate 50 mg tablet, film coated | Generic | $4.39 per tablet |
| doxycycline hyclate 60 mg tablet, delayed release | Brand: Doryx Mpc | $18.18 per tablet |
| doxycycline hyclate 75 mg tablet | Generic | $0.5482 per tablet |
| doxycycline hyclate 75 mg tablet, coated | Generic | $0.5482 per tablet |
| doxycycline hyclate 75 mg tablet, film coated | Generic | $0.5482 per tablet |
NADAC list of November 4, 2026; these prices took effect between December 17, 2025 and 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.
- Bryant Ranch Prepack22 products
- A-S Medication Solutions17 products
- Proficient Rx LP16 products
- Chartwell RX, LLC16 products
- Remedyrepack Inc.15 products
- Alembic Pharmaceuticals Inc.14 products
- Alembic Pharmaceuticals Limited14 products
- PD-Rx Pharmaceuticals, Inc.13 products
- Strides Pharma Science Limited13 products
- Zydus Lifesciences Limited12 products
- Sun Pharmaceutical Industries, Inc.11 products
- Lupin Pharmaceuticals, Inc.11 products
- NuCare Pharmaceuticals, Inc.10 products
- Zydus Pharmaceuticals USA Inc.9 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.8 products
- Direct_Rx7 products
- Chartwell Governmental & Specialty RX, LLC.5 products
- AvPAK5 products
- American Health Packaging5 products
- Asclemed USA, Inc.4 products
- Ajanta Pharma USA Inc.4 products
- Solco Healthcare US, LLC4 products
- Advanced Rx Pharmacy of Tennessee, LLC4 products
- Hikma Pharmaceuticals USA Inc.4 products
- Redpharm Drug4 products
- Northwind Health Company, LLC4 products
- Lannett Company, Inc.4 products
- Actavis Pharma, Inc.3 products
- Fresenius Kabi USA, LLC3 products
- Coupler LLC3 products
- Viona Pharmaceuticals Inc3 products
- Health Department, Oklahoma State3 products
- Macleods Pharmaceuticals Limited3 products
- Zhejiang Yongtai Pharmaceutical Co., Ltd2 products
- Major Pharmaceuticals2 products
- Cardinal Health 107, LLC2 products
- Cranbury Pharmaceuticals, LLC2 products
- Amneal Pharmaceuticals NY LLC2 products
- Preferred Pharmaceuticals Inc.2 products
- RedPharm Drug, Inc.2 products
- Mayne Pharma Commercial LLC2 products
- Sportpharm LLC2 products
- Golden State Medical Supply, Inc.2 products
- Epic Pharma, LLC2 products
- St. Mary's Medical Park Pharmacy2 products
- Safecor Health LLC2 products
- JG Pharma Inc.1 product
- Diirect_rx1 product
- Unit Dose Solutions, Inc.1 product
- Puracap Laboratories LLC dba Blu Pharmaceuticals1 product
- Camber Pharmaceuticals, Inc.1 product
- Acella Pharmaceuticals, LLC1 product
- Hikma Pharmaceutical1 product
- Larken Laboratories, Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Novel Laboratories, Inc.1 product
- Meitheal Pharmaceuticals Inc.1 product
- HF Acquisition Co LLC, DBA HealthFirst1 product
- Aqua Pharmaceuticals1 product
- Dr. Reddy's Laboratories Inc.1 product
- Mylan Institutional LLC1 product
- Jvet Pharmaceuticals LLC1 product
- Piramal Critical Care Inc1 product
- Henry Schein, Inc.1 product
- Quality Care Products, LLC1 product
- Fosun Pharma USA Inc.1 product
- Avenacy Inc.1 product
- Par Health USA, LLC1 product
- Gland Pharma Limited1 product
- Sonoma Pharmaceuticals, Inc.1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Hawaii Repack, Inc.1 product
- QPharma, Inc.1 product
- Steriscience Specialties Private Limited1 product
- Journey Medical Corporation1 product
- Apotex Corp.1 product
- AvKARE1 product
- AiPing Pharmaceutical, Inc.1 product
- Wellhouse Pharma, LLC1 product
- Galderma Laboratories, L.P.1 product
- Mayne Pharma Inc.1 product
- Dr.Reddys Laboratories Inc1 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 |
|---|---|---|---|
| NDA050641 MONODOX | Chartwell Rx | December 29, 1989 | 19, latest March 31, 2025 2025: Labeling · 2024: Labeling · 2022: Manufacturing (CMC) |
| NDA050795 DORYX, DORYX MPC | Mayne Pharma | May 6, 2005 | 21, latest March 31, 2025 2025: Labeling · 2024: Manufacturing (CMC) · 2022: Labeling |
| NDA050805 ORACEA | Galderma Labs LP | May 26, 2006 | 7, latest April 2, 2025 2025: Labeling · 2021: Labeling · 2015: Manufacturing (CMC) |
| NDA205931 ACTICLATE | Chartwell Rx | July 25, 2014 | 5, latest March 31, 2025 2025: Labeling · 2020: Labeling · 2019: Labeling |
| NDA208253 ACTICLATE CAP | Chartwell Rx | April 26, 2016 | 4, latest March 31, 2025 2025: Labeling · 2020: Labeling · 2019: Labeling |
Generic approvals (67)
- ANDA062269Epic Pharma LLC · November 8, 1982
- ANDA062421Actavis Labs Fl Inc · February 2, 1983
- ANDA062475Fresenius Kabi USA · December 9, 1983
- ANDA062500Chartwell · September 11, 1984
- ANDA062505Chartwell · September 11, 1984
- ANDA062396Hikma · November 7, 1984
- ANDA062538Strides Pharma Intl · April 7, 1986
- ANDA062676Sun Pharm Industries · July 10, 1986
- ANDA062677Sun Pharm Industries · July 10, 1986
- ANDA062992West-Ward Pharms Int · February 16, 1989
- ANDA065053Sun Pharm Inds Ltd · November 22, 2000
- ANDA065055Strides Pharma Intl · December 1, 2000
- ANDA065070Strides Pharma Intl · December 15, 2000
- ANDA065095Hikma · July 2, 2003
- ANDA065134Sun Pharm Industries · May 13, 2005
- ANDA065182Epic Pharma LLC · May 13, 2005
- ANDA065277Chartwell Molecular · November 10, 2005
- ANDA065285Lannett Co Inc · December 8, 2005
- ANDA065287Pharmobedient · February 28, 2006
- ANDA065356Sun Pharm Inds Ltd · May 31, 2006
- ANDA065454Chartwell · July 16, 2008
- ANDA090134Actavis Elizabeth · December 14, 2011
- ANDA091605Heritage · December 20, 2011
- ANDA091406Mylan Labs Ltd · August 21, 2012
- ANDA201678Lupin Ltd · March 18, 2013
- ANDA200856Heritage · April 30, 2013
- ANDA204234Lupin · March 5, 2014
- ANDA204446Cosette Pharms Nc · May 28, 2015
- ANDA205115Zydus Pharms · February 18, 2016
- ANDA207289Amneal Pharms · June 27, 2016
- ANDA207494Prinston Inc · November 15, 2016
- ANDA209165Alembic · July 28, 2017
- ANDA207558Novel Labs Inc · September 6, 2017
- ANDA208818Lupin · September 27, 2017
- ANDA207757Zydus Pharms · September 28, 2017
- ANDA209582Zydus Pharms · September 28, 2017
- ANDA207773Zydus Lifesciences · October 30, 2017
- ANDA207774Zydus Lifesciences · May 31, 2018
- ANDA210527Alembic · June 13, 2018
- ANDA211012Ajanta Pharma Ltd · September 24, 2018
Showing the 40 earliest of 67.
Shortage status
To be discontinued · updated July 30, 2026 · first posted July 30, 2026
| Product | Doxycycline Hyclate, Tablet, Delayed Release, 50 mg (NDC 0591-4550-22) |
|---|---|
| Company | Teva Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
September 29, 2025 · Class II · Ongoing · D-0014-2026
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05. — Acella Pharmaceuticals, LLC
-
April 13, 2022 · Class II · Terminated · D-1032-2022
cGMP deviations: Temperature abuse
Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Distributed by: Sun Pharmaceuticals, NDC 63304-616-50 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-1054-2022
cGMP deviations: Temperature abuse
Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each blister pack x 5), Rx only, MFG: Major Pharma, NDC 0904-0430-06 — Mckesson Medical-Surgical Inc. Corporate Office
-
January 26, 2022 · Class II · Terminated · D-0178-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08 — CARDINAL HEALTHCARE
-
May 22, 2020 · Class II · Terminated · D-1288-2020
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distribu — The Harvard Drug Group
-
May 19, 2020 · Class II · Terminated · D-1293-2020
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11 — American Health Packaging
-
May 15, 2020 · Class II · Terminated · D-1276-2020
Failed dissolution specifications
Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28), — PD-Rx Pharmaceuticals, Inc.
-
May 13, 2020 · Class II · Terminated · D-1274-2020
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. — West-Ward Columbus Inc
-
March 13, 2020 · Class II · Terminated · D-1032-2020
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01. — Sun Pharmaceutical Industries, Inc.
-
March 13, 2020 · Class II · Terminated · D-1033-2020
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50. — Sun Pharmaceutical Industries, Inc.
-
August 7, 2018 · Class II · Terminated · D-1127-2018
Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bot — PD-Rx Pharmaceuticals, Inc.
-
August 1, 2018 · Class II · Terminated · D-1582-2019
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-1 — American Health Packaging
-
July 30, 2018 · Class II · Terminated · D-1026-2018
Failed Dissolution Specifications
Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Sui — MAJOR PHARMACEUTICALS
-
July 24, 2018 · Class II · Terminated · D-1025-2018
Failed Dissolution Specifications:
Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05. — West-Ward Columbus Inc
-
July 24, 2018 · Class II · Terminated · D-1024-2018
Failed Dissolution Specifications:
Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50. — West-Ward Columbus 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) | 283535, 310027, 406524, 434018, 544840, 700408, 728207, 799048, 901399, 901401 … (+10) |
|---|---|
| SPL set ID of the quoted label | 5e96d473-63dd-4446-88cf-eef2cd3339f0 |
| FDA labels (SPL) | 236 |
| FDA applications | NDA050641, NDA050795, NDA050805, NDA205931, NDA208253, 67 ANDA |
| Active ingredients (FDA) | DOXYCYCLINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Acticlate CAP, Aqua Pharmaceuticals, effective November 28, 2017; 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 →