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 |
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.
How to identify the recalled item
| Lot / date codes | Lot No: GMML24026A, Expires: 09/30/2027 |
|---|---|
| Lot / date codes | Lot: ZBUL25001, Exp 12/31/2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.