Cyclobenzaprine Recall: Unichem 10 mg 90-count Rx bottle
Announced 2026-05-13 · FDA
FDA recall due to a labeling mix-up: Meloxicam USP 7.5 mg 90-count bottles were labeled as Cyclobenzaprine Hydrochloride Tablets USP 10 mg 90-count bottles. A total of 230 bottles were distributed nationwide. The affected bottles have NDC 29300-415-19, lot GMML24026A, and expire 09/30/2027.
| Brand | Unichem Pharmaceuticals USA Inc. |
|---|---|
| Product | 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. |
| Reason | 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). |
| Severity | critical |
| Units affected | 10875 |
| Distribution | Nationwide within the U.S.A |
| Agency | FDA |
| Recall / campaign no. | Lot No: GMML24026A, Expires: 09/30/2027 |
WHAT YOU SHOULD DO
- Do not use the recalled product if you have a bottle with lot GMML24026A or that may be mislabeled.
- Contact your pharmacist or healthcare provider for instructions and guidance on return, replacement, or disposal.
- If you have questions, reach out to the dispensing pharmacy or Unichem Pharmaceuticals USA for further instructions.
- If you experience any adverse symptoms, seek medical attention promptly.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.