Cyclobenzaprine Hydrochloride Tablets — Class I drug recall D-0655-2025
Ongoing recall by Unichem Pharmaceuticals USA Inc., reported 2025-09-24, distributed nationwide. Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as C
| Recall number | D-0655-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unichem Pharmaceuticals USA Inc., East Brunswick, NJ, United States |
| Recall initiated | 2025-08-27 |
| Classified | 2025-09-17 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 29300-0413, 29300-0413-01, 29300-0413-05, 29300-0413-10, 29300-0413-19, 29300-0414, 29300-0414-01, 29300-0414-10, 29300-0415, 29300-0415-01, 29300-0415-05, 29300-0415-10, 29300-0415-19 |
| Lot numbers | GMML24026A |
| Expiration dates | 2027-09-30 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0655-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.