CLASS I ONGOING Drug recall · Reported 24 Sep 2025 · FDA Enforcement Report
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg recalled
Unichem Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, distributed nationwide in the US. The recall was initiated on 27 Aug 2025 and the FDA has classified it as Class I.
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-0655-2025
- FDA event ID
- 97482
- Recalling firm
- Unichem Pharmaceuticals USA, East Brunswick, NJ
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 27 Aug 2025
- FDA classified
- 17 Sep 2025
- Reported
- 24 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
Timeline
| 27 Aug 2025 | Recall initiated by company | |
| 17 Sep 2025 | Classified by FDA | +21 days |
| 24 Sep 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Product as listed by the FDA
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
Where it was distributed
Nationwide within the U.S.A
Questions about this recall
Is Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg recalled?
Yes. Unichem Pharmaceuticals USA recalled Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg on 27 Aug 2025. The recall is Class I and its status is Ongoing. Recall number D-0655-2025.
Why was it recalled?
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Which lots are affected?
Lot No: GMML24026A, Expires: 09/30/2027
Where was it sold?
Nationwide within the U.S.A
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
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Other Cyclobenzaprine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cyclobenzaprine Hydrochloride Tablets, 5mg tablets recalled | Teva Pharmaceuticals U | Mold | Nationwide |
| Drug | CLASS II | Cyclobenzaprine Hydrochloride Tablets, 5mg tablets recalled | Teva Pharmaceuticals U | Mold | Nationwide |
| Drug | CLASS II | Cyclobenzaprine Hydrochloride Tablets, 5mg tablets recalled | Teva Pharmaceuticals U | Mold | Nationwide |
| Drug | CLASS II | Cyclobenzaprine HCl USP for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | Cyclobenzaprine HCl Tablets, USP, 5 mg Unit Dose recalled by Apace KY | Apace KY | Other | KY |