CLASS II ONGOING Drug recall · Reported 7 May 2025 · FDA Enforcement Report
Clindamycin Hydrochloride Capsules, USP, 300mg recalled
Preferred Pharmaceuticals is recalling Clindamycin Hydrochloride Capsules, USP, 300mg, distributed nationwide in the US. The recall was initiated on 18 Apr 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0391-2025
- FDA event ID
- 96756
- Recalling firm
- Preferred Pharmaceuticals, Anaheim, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Apr 2025
- FDA classified
- 28 Apr 2025
- Reported
- 7 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Antibiotics
Timeline
| 18 Apr 2025 | Recall initiated by company | |
| 28 Apr 2025 | Classified by FDA | +10 days |
| 7 May 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations
Product as listed by the FDA
Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
cGMP Deviations
Which lots are affected?
Lot #: L0224T, K1824M, K0124N, J1624V, J0824O, I2424E, I1024O, A0925F, L2324L, Exp: 7/31/2026.
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Preferred Pharmaceuticals
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears | Preferred Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled | Preferred Pharmaceuticals | Packaging Defects | CA |
| Drug | CLASS II | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled | Preferred Pharmaceuticals | Potency & Assay | CA, NV |
| Drug | CLASS II | Duloxetine Delayed-Release Cap USP 30mg recalled | Preferred Pharmaceuticals | Nitrosamine Impurity | 5 states |
| Drug | CLASS II | Tizanidine Hydrochloride Tablet 4mg recalledTizanidine | Preferred Pharmaceuticals | Potency & Assay | Nationwide |
Other Clindamycin recalls
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 600 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |