Prescription medicine
Clindamycin Brand names: Cleocin, Clindagel, Xaciato, Clindesse; first approved as Cleocin Hydrochloride
Clindamycin (Cleocin) is a prescription medicine with an FDA approval on record since 1970. FDA's NDC Directory lists it from 60 generic labelers, and pharmacies paid $0.137 per gram (Clindamycin ph 1% gel) in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
- Boxed warning
Check it at the source: the clindamycin FDA label on DailyMed (effective March 10, 2026, GLENMARK PHARMACEUTICALS INC., USA); the NDA 50162 record on Drugs@FDA; every clindamycin label on DailyMed.
Highlights of the record
FDA label of March 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile. Because clindamycin hydrochloride therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C . difficile may need to be discontinued. […]
Used for
From the label: indications and usageClindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Forms and strengths
- 10 mg
- 75 mg
- 100 mg
- 150 mg
- 300 mg
- 1 g/100ml
- 1 g/10ml
- 6 mg/ml
- 10 mg/ml
- 10 mg/g
- 11.9 mg/ml
- 12 mg/ml
Capsule; injection (solution); solution; gel; lotion.
On the market
- Earliest approval on file
- February 22, 1970 Cleocin Hydrochloride, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 86 first February 8, 1982; 51 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 65 of which 60 under generic applications, 8 under brand applications, repackagers included
- Last listed patent
- September 22, 2036 Xaciato gel; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.137 per gram Clindamycin ph 1% gel
- Shortage (FDA)
- 6 of 28 presentations limited or unavailable updated October 2, 2026
- Recalls by its makers (FDA)
- 24 since 2012 0 Class I among all firms' recalls; latest August 6, 2026; 7 more by firms not listed as its makers
- FAERS reports
- 8,968 through July 30, 2026
What is clindamycin used for?
From the label: indications and usageClindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). […]
Conditions named in the indications of clindamycin's FDA labels, with every medicine labeled for each:
From other clindamycin labelsBacterial infections: INDICATIONS AND USAGE Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Acne: INDICATIONS AND USAGE Clindamycin Phosphate Topical Solution is indicated in the treatment of acne vulgaris.
FDA pharmacologic class: Lincosamide Antibacterial.
Source: FDA drug label (Clindamycin Hydrochloride), GLENMARK PHARMACEUTICALS INC., USA, effective March 10, 2026 (SPL set 8e66de7a-d9d4-4562-bc99-80489d482da4), via openFDA; the full label on DailyMed
What does the patient leaflet for clindamycin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using XACIATO?After you insert XACIATO: Do not have vaginal sex or use vaginal products (such as tampons or douches) during treatment with XACIATO and for 3 days after using XACIATO. You should not use polyurethane condoms during treatment with XACIATO and for 7 days after using XACIATO. XACIATO may weaken polyurethane condoms and they may not work well for preventing pregnancy or protecting against Human Immunodeficiency Virus (HIV) and other sexually transmitted diseases (STDs). Latex or polyisoprene condoms should be used.
From the patient leaflet: How should I store XACIATO?Store XACIATO at room temperature between 68ºF and 77ºF (20ºC to 25ºC). Keep XACIATO and all medicines out of the reach of children.
Source: FDA drug label (XACIATO), Organon LLC, effective February 19, 2026 (SPL set 0423007f-28fa-4159-bf58-9174626d2347), via openFDA; the full label on DailyMed
Is there a generic for clindamycin (Cleocin)?
The FDA approved the first generic clindamycin on February 8, 1982. 86 generic applications are approved; 51 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists clindamycin from 60 labelers under a generic (ANDA) application and from 8 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Cleocin Phosphate injection; a patent listed only for Xaciato gel runs to September 22, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1970 earliest approval on file
- 1982 first generic approved
- 2036 last listed patent
- 2023 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for clindamycin (Cleocin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.137 per gram (Clindamycin ph 1% gel), down 10% from $0.152 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Clindamycin ph 1% gel (generic)
- Cleocin 2% vaginal cream (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clindacin 1% foam | Generic | $1.83 per gram | n/a | -47% |
| Clindamycin (pedi) 75 mg/5 mL | Generic | $0.129 per mL | n/a | -24% |
| Clindamycin 2% vaginal cream | Generic | $1.86 per gram | n/a | +18% |
| Clindamycin HCl 150 mg capsule | Generic | $0.103 per capsule | $3.08 | -0.8% |
| Clindamycin HCl 300 mg capsule | Generic | $0.175 per capsule | $5.24 | -4% |
| Clindamycin HCl 75 mg capsule | Generic | $0.259 per capsule | $7.76 | -18% |
| Clindamycin ph 1% gel | Generic | $0.137 per gram | n/a | -10% |
| Clindamycin ph 1% solution | Generic | $0.164 per mL | n/a | -20% |
| Clindamycin phos 1% pledget | Generic | $0.285 per unit | n/a | -9% |
| Clindamycin phosp 1% lotion | Generic | $0.245 per mL | n/a | -23% |
| Clindamycin phosphate 1% foam | Generic | $2.02 per gram | n/a | -40% |
| Clindamycin phosphate 1% gel | Generic | $3.40 per mL | n/a | -56% |
| Cleocin 100 mg vaginal ovule | Brand | $60.18 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +2% |
| Cleocin 2% vaginal cream | Brand | $1.79 per gram | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is clindamycin in shortage?
The FDA Drug Shortage Database lists 6 of 28 clindamycin presentations as limited or unavailable (updated October 2, 2026); the first entry was posted on March 21, 2023. 11 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Cleocin Phosphate, Injection, Cleocin Phosphate 300 mg/2 mL (150 mg/mL) (NDC 0009-0870-26) | Pfizer Inc. | Current | September 21, 2026 |
| Cleocin Phosphate, Injection, Cleocin Phosphate 600 mg/4 mL (150 mg/mL) (NDC 0009-0775-26) | Pfizer Inc. | Current | September 21, 2026 |
| Cleocin Phosphate, Injection, Cleocin Phosphate 900 mg/6 mL (150 mg/mL) (NDC 0009-0902-18) | Pfizer Inc. | Current | September 21, 2026 |
| Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 12 mg/1 mL (NDC 0781-3289-09) | Sandoz Inc. | Current | September 18, 2026 |
| Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 12 mg/1 mL (NDC 72572-074-24) | Sandoz Inc. | Current | September 18, 2026 |
| Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 18 mg/1 mL (NDC 0781-3290-09) | Sandoz Inc. | Current | September 18, 2026 |
| Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 18 mg/1 mL (NDC 72572-076-24) | Sandoz Inc. | Current | September 18, 2026 |
| Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 6 mg/1 mL (NDC 0781-3288-09) | Sandoz Inc. | Current | September 18, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has clindamycin been recalled?
The FDA's Enforcement Report lists 31 recalls naming clindamycin since 2012: 0 Class I (the most serious), 23 Class II, 8 Class III; 12 still ongoing. 7 of them are by firms that FDA's NDC Directory does not list as a maker of clindamycin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 6, 2026 | Class II | Baxter Healthcare Corporation | CGMP Deviations |
| July 30, 2026 | Class II | Heritage Pharmaceuticals Inc | Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. |
| November 26, 2025 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. |
| April 22, 2025 | Class II | RemedyRePack Inc. | CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets. |
| April 18, 2025 | Class II | Preferred Pharmaceuticals, Inc. | cGMP Deviations |
| March 24, 2025 | Class II | RemedyRepack Inc. | CGMP Deviations |
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| February 20, 2024 | Class III | Contract Pharmaceuticals Limited Canada | Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the clindamycin label say about other medicines?
The clindamycin label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 3 other medicines name clindamycin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lincomycin | contraindications | CONTRAINDICATIONS Clindamycin hydrochloride capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin. |
Source: FDA drug label (Clindamycin Hydrochloride), GLENMARK PHARMACEUTICALS INC., USA, effective March 10, 2026 (SPL set 8e66de7a-d9d4-4562-bc99-80489d482da4), via openFDA; the full label on DailyMed
What do FAERS reports show for clindamycin?
The FDA Adverse Event Reporting System holds 8,968 reports that list clindamycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 627 are coded as a death and 2,965 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as clindamycin?
23 other medicines are given the same way (oral) and in the same FDA class as clindamycin or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Amoxicillin | Bacterial infections | 38 labelers | $0.0788 per capsule 500 mg capsule | No current entry |
| Azithromycin | Bacterial infections | 47 labelers | $0.266 per tablet 250 mg tablet | A presentation being discontinued |
| Cephalexin | Bacterial infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Metronidazole | Bacterial infections | 40 labelers | $0.102 per tablet 250 mg tablet | In shortage |
| Sulfamethoxazole and trimethoprim | Bacterial infections | 42 labelers | $0.0448 per tablet Sulfamethoxazole-tmp ds tablet | No current entry |
| Levofloxacin | Bacterial infections | 35 labelers | $0.259 per tablet 750 mg tablet | No current entry |
| Cefdinir | Bacterial infections | 26 labelers | $0.458 per capsule 300 mg capsule | No current entry |
| Erythromycin | Bacterial infections | 22 labelers | $1.96 per tablet 250 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does clindamycin compare with medicines for the same use?
24 side-by-side pages set clindamycin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other lincosamide antibacterials
- the pharmacologic class, with prices and generics
- Clindamycin side effects
- the label's list beside FAERS reports
- Clindamycin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other