CLASS II ONGOING Drug recall · Reported 2 Aug 2023 · FDA Enforcement Report
Diclofenac Sodium Topical Solution USP, 2% w/w recalled
Alembic Pharmaceuticals is recalling Diclofenac Sodium Topical Solution USP, 2% w/w, distributed nationwide in the US. The recall was initiated on 22 Jun 2023 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-0941-2023
- FDA event ID
- 92581
- Recalling firm
- Alembic Pharmaceuticals, Bedminster, NJ
- Brand
- Diclofenac Sodium
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jun 2023
- FDA classified
- 24 Jul 2023
- Reported
- 2 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 22 Jun 2023 | Recall initiated by company | |
| 24 Jul 2023 | Classified by FDA | +32 days |
| 2 Aug 2023 | 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
Defective Delivery System
Product as listed by the FDA
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Diclofenac Sodium Topical Solution USP, 2% w/w recalled?
Yes. Alembic Pharmaceuticals recalled Diclofenac Sodium Topical Solution USP, 2% w/w on 22 Jun 2023. The recall is Class II and its status is Ongoing. Recall number D-0941-2023.
Why was it recalled?
Defective Delivery System
Which lots are affected?
Lot #: 220151, 220152, 220153, Exp. Date 11/2024
Where was it sold?
Nationwide within the United States
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 21 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 Alembic Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 8 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 4 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxepin Hydrochloride Capsules, USP, 10 mg recalledDoxepin Hydrochloride | Alembic Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Celecoxib Capsules, 200 mg recalled by Alembic PharmaceuticalsCelecoxib | Alembic Pharmaceuticals | Hidden Drug Ingredients | Nationwide |
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Other Diclofenac recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diclofenac Sodium, Topical Gel, 3% tube recalledDiclofenac Sodium | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Diclofenac Sodium Topical Gel recalled by Cipla USADiclofenac Sodium | Cipla USA | Other | Nationwide |
| Drug | CLASS II | Altaire Diclofenac Sodium Opthalmic Solution recalledDiclofenac | Altaire Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Altaire Diclofenac Sodium Opthalmic Solution recalledDiclofenac | Altaire Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Diclofenac Sodium USP for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |