Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind
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).
- Agency
- FDA Drug
- Recall date
- Aug 27, 2025
- Status
- Ongoing
- Company
- Unichem Pharmaceuticals USA Inc.
1. What product was recalled?
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind
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.
Quantity: 230 90-count bottles
Code or lot text: Lot No: GMML24026A, Expires: 09/30/2027
- LOT
- Expires: 09/30/2027
- LOT
- Lot No: GMML24026A
- NDC
- 29300-413
- NDC
- 29300-413-01
- NDC
- 29300-413-05
- NDC
- 29300-413-10
- NDC
- 29300-413-19
- NDC
- 29300-414
- NDC
- 29300-414-01
- NDC
- 29300-414-10
- NDC
- 29300-415
- NDC
- 29300-415-01
- NDC
- 29300-415-05
- NDC
- 29300-415-10
- NDC
- 29300-415-19
- RECALL-NUMBER
- D-0655-2025
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
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).
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Drug source
The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.