Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Clindamycin Hydrochloride Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
Affected NDC
68788-8685-03
Compare with the code on your package — it is the most precise check available.
Drug: Clindamycin Category: Antibiotic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Clindamycin Hydrochloride NDC 68788-8685 |
300 mg/1 | Capsule Oral |
Preferred Pharmaceuticals Inc. | Rx |
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- NDC code
- 68788-8685-03
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0391-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Clindamycin recalls
See all
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Class II · Moderate risk
Clindamycin Phosphate in 0.9% Sodium Chloride Injection
CGMP Deviations
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Other recalls by Preferred Pharmaceuticals, Inc.
All 2025 recalls
Class II · Moderate risk
Artificial Tears Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Ondansetron ODT Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk
Ibuprofen Tablets
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Class II · Moderate risk
Duloxetine Delayed-Release Cap USP 30mg
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.